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post market surveillance | MDR | IVDR | PSUR periodic safety update report

Overcoming the Most Common Periodic Safety Update Report (PSUR) and Post-Market Surveillance (PMS) Report Challenges

— coauthored by Jan Kloiber, Senior Principal Specialist and Celeste Maksim, Chief of Staff, Clinical and Post-Market Services May 2022 is the one-year milestone for EU MDR and the date of application for IVDR. For medical devices that have already been approved under MDR, annual periodic safety update reports (PSURs) are due for Class IIb and III devices. Since this is the first year and there is still no official guidance, many manufacturers are struggling with meeting the new regulatory requirements.
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MDR | regulatory | IVDR

How Your Medical Director Can Help You Scope SOTA Properly: A Physician's Perspective

State of the art (SOTA) is a key element of the technical documentation required for MDR/IVDR certification. As a new requirement for devices in lower-risk classes, many manufacturers are struggling to provide SOTA context that meets notified body expectations. Whether for new devices or those that have been on the market for a long time, physicians can help manufacturers overcome many of these challenges.
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IVDR

IVDR State of the Art (SOTA)

— coauthored by Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation - IVD and Carlos Galamba, RQM+ VP Intelligence & Innovation - IVD  State of the art (SOTA) is a key piece of the IVDR puzzle. Like many of the other required elements, it touches multiple sections of your technical documentation and must be consistently addressed throughout.
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EU MDR

A Quantitative Approach to Benefit-Risk Determination

Under the Medical Device Regulation (2017/745) (MDR), demonstrating clinical benefit and quantifying benefit-risk ratios are critical to compliance. A medical device must not be placed on the market if the benefit of the product does not outweigh the risk in a clearly quantified and documented benefit-risk analysis. Qualitative arguments are inherently subjective to some degree – an issue that can be addressed by a quantitative approach.
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IVDR

Risk Management Challenges with IVDR Compliance - This May Be Your Biggest Obstacle

Co-authored by Amie Smirthwaite BEng, PhD, RQM+ Senior VP, Intelligence & Innovation IVD manufacturers have had to make significant improvements to their risk files since the days of IVDD. What was once the reality—static and often incomplete files that hardly changed after being placed on the market—is no longer acceptable. However, despite making major headway in recent years, risk management is among the top issues IVD manufacturers are facing when it comes to IVDR compliance.
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EU | IVDR

What You Need to Know About Significant Changes Under IVDR

Co-authored by Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation Until recently, many IVD manufacturers were able to make changes to the design or intended use of their devices with minimal consequences under IVDD (98/79/EC). With the transition to IVDR and the date of application just around the corner, that time window is quickly closing. As of 26 May 2022, IVD manufacturers will no longer be able to make changes to the intended purpose or design of a device under IVDD, and all classes of IVDs will be subject to IVDR regulations.
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MDR

Using Chemical Characterization to Achieve Biological Equivalence

In the EU, a device is considered to be equivalent if and only if it fulfills all the requirements of technical, clinical, and biological equivalence. Of these, biological equivalence tends to be the most nuanced and can be a confusing topic for medical device manufacturers—especially since regulators in different global regions don’t always take the same approach. Chemical characterization, which tends to get ignored—but is now a requirement per MDR, Annex II, section 6.1(b)—can help make claiming biological equivalence more feasible when “similarities/differences” exist.
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FDA | COVID-19

How to Prepare for COVID-19 EUA or Enforcement Policy Expiration

By: Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)
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MDR | IVDR

Europe: 2021 Year-End Review & Looking Ahead to 2022

Co-authored by Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation and Nancy Morrison, RQM+ Executive Director, Regulatory & Consulting Services 2021 was another big year in the European regulatory realm as EU MDR and IVDR implementation continued to roll out. Let’s take a look at the highlights and lessons learned that we can apply as we go into 2022.
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IVD | IVDR

Just Released: MDCG Guidance 2022-3 Verification of Manufactured Class D IVDs by Notified Bodies

The MDCG guidance 2022-3 Verification of manufactured class D IVDs by notified bodies was issued earlier this week on the 15th of February 2022. This guidance is important for manufacturers because it provides a detailed specification of the requirements for the testing plan and agreements for batch verification that must be in place between manufacturers, Notified Bodies (NBs) and EU Reference Laboratories (EURLs) to maintain a Class D product on the EU market. Without a successful batch verification process a Class D products is not permitted to be placed on the EU market.
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team members | IVDR

Dr. Heike Moehlig-Zuttermeister Joins RQM+ as IVD Vice President Intelligence and Innovation

RQM+ is excited to announce the addition of Dr. Heike Moehlig-Zuttermeister as IVD Vice President Intelligence and Innovation. Heike joins us after nearly eight years at BSI, where she held leadership roles within the IVD team.
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FDA | MDR

Software as a Medical Device

Advancements in technology over the past several decades have naturally led to advancements in healthcare. Software as a medical device (SaMD) is particularly poised for growth with one of the latest advancements: the Internet of Things (IoT). Because of this and other factors, the SaMD market is expected to grow at a compound annual growth rate of 21.9 percent from 2020 to 2027, bringing the value to just over $86 million. This growth represents potential lifesaving innovation for providers and patients. However, for manufacturers, especially those that are new to SaMD, it represents new complications in regulatory affairs and risk management.
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IVD | COVID-19

EU Update: Expert Panel Views for SARS-CoV-2 Devices

The first three Performance Evaluation Consultation Procedure (PECP) views have been published for a professional SARS-CoV-2 immunoassay and a professional nucleic acid testing (NAT) assay as well as a near-patient testing NAT SARS-CoV-2 product. Considering the actual criticality of these devices, these expert panel views are a big milestone to speed up conformity assessment work conducted by notified bodies (NB) to achieve In Vitro Diagnostic Regulation (IVDR) CE marking.
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In case you missed it: 2021 Expert Content from the RQM+ Knowledge Center

“RQM+ is always the first resource I think of when assistance is needed. In addition I cannot state how grateful I am for your organizations thought leadership and resources/content. It’s best in class!” In 2021, we launched the RQM+ Knowledge Center as your one-stop-shop to access a filterable library of content brought to you by our expert team's unrivaled collective knowledge.   Below is a recap of some of our content produced throughout 2021. You can always find each of these resources as well as all of the content we've produced so far in 2022 in our Knowledge Center. Be sure to subscribe to our blog to receive timely industry news, technical briefs, and expert content straight to your inbox. Please note: The content listed below was created prior to the announcement of the extension to the IVDR transition period. Check out the RQM+ Executive Video Briefing: IVDR New Transition Timelines for a more recent review of the revised IVDR timeline.
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medical device | United States

FDA CDRH: What will they do in 2022?

By: Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer) “It’s tough to make predictions, especially about the future.” Whether baseball Hall of Famer-slash-philosopher Yogi Berra actually said these words or not, the sentiment rings true, as anyone who has tried to predict the course of the COVID-19 pandemic would know. Predicting when the Center for Devices and Radiological Health (CDRH) at the U.S. Food & Drug Administration (FDA) will return back to normal is also no exception. Just as things were starting to look up, the Omicron coronavirus variant has appeared to put another wrench in FDA’s plans. This has delayed FDA’s in-person return to the office and caused FDA to postpone non-mission critical inspections until February 2022.[1] While FDA’s COVID-19 response is still the Agency’s number one priority, there are other important changes to be aware of in 2022.
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post market surveillance | MDR

Best Practices and Processes for Integrating CERs and Post-Market Surveillance Under EU MDR

The EU MDR date of application has come and gone, and most manufacturers are well aware of the new requirements. However, awareness does not necessarily equal effective implementation. One of the main challenges of MDR compliance is creating a strategy that integrates the work of multiple teams, including regulatory, quality, risk management, clinical, and more.
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IVD

RQM+ Executive Video Briefing: IVDR New Transition Timelines

While we are happy and relieved for the IVD industry to have an extension to the IVDR transition period, we’re concerned that the announcement may result in a misperception that there is plenty of time to get the work done.
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IVDR | EU MDR

MDR and IVDR Mock Technical Assessments and Design Examinations

— coauthored by Amie Smirthwaite, BEng, Ph.D., SVP, Intelligence & Innovation and Carlos Galamba, BSc, MSc, VP, Intelligence & Innovation - IVD With the rollout of EU MDR and IVDR, manufacturers are facing new challenges, especially when it comes to technical documentation review. Medical device and IVD manufacturers are accustomed to doing mock audits for quality systems and ISO certification, but these types of assessments are a relatively new concept in the regulatory realm. 
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FDA

FDA CDRH 2021: A Year in Review

By: Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer). Looking back to 2020, as the COVID-19 pandemic gripped the world, much of the FDA’s focus turned to their response to the public health emergency. CDRH in particular reviewed thousands of emergency use authorization (EUA) applications and worked to facilitate the development and availability of COVID-19 tests and collection kits, personal protective equipment (PPE), ventilators, and other devices. Despite this shift in focus, CDRH also received an increase in “conventional” premarket submissions, such as 510(k)s, De Novos, Premarket Approvals (PMAs), Q-Submissions (Q-Subs), and surprisingly even IDEs. Overall, this amounted to a massive 38% increase to CDRH’s premarket submission workload).1
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EU | IVD

The IVDR Performance Evaluation Report

Under the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), every IVD must have a Performance Evaluation Report (PER). PERs consist of three pillars: scientific validity, analytical performance and clinical performance. Collating data to satisfactorily address each pillar must be a priority for IVD manufacturers. With notified bodies under severe pressure and resource limitations, they will not engage with manufacturers who cannot demonstrate that they have processes for IVDR compliance in place.
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medical device

EU MDR Article 61 and equivalence – is there a new way forward?

About this article: Could there be more scope for use of equivalence data under EU MDR than you may have thought? Dr. Amie Smirthwaite, Sr. VP of Global Intelligence & Innovation at RQM+, EU MDR expert, thought leader, and member of the working groups that authored MDCG 2020-5 and 2020-6, has put a lot of thought into MDR Article 61 and the associated requirements around equivalence and sufficient clinical evidence. From the early days of implementing the MDR at BSI until now, five years later, supporting the industry in a consultancy role, Amie has found the wording of this article to be puzzling, creating unnecessary challenges for both notified bodies and manufacturers. Amie and the RQM+ team hope that the position taken in this blog will be food for thought for the European Commission, competent authorities and notified bodies, allowing a bit more flexibility for certifying devices that offer a real benefit to patients.
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medical device | ROW

UK Approved Bodies: on your UKCA mark, get set, go!

The world of medical device regulation has seen immense change in past years. The EU MDR has been at the forefront of every agenda for some time – and the one-year deadline delay provided valuable extra time for businesses to get their act together. That one-year delay also meant that the EU MDR was not implemented into UK legislation before the UK exited from the EU. The UK’s departure from the EU has now added a whole new set of regulatory requirements into the mix. Trading with the UK just got a bit more complicated!
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EU | IVD

Clinical Evidence Requirements Under IVDR

The next key regulatory milestone for manufacturers with products on the European market is the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). A critical stage of IVDR planning is for manufacturers to assess whether they have enough clinical and performance data that meets notified body expectations.
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medical device | ROW

What do we know so far about post-Brexit medical device regulation?

What do we know so far about post-Brexit medical device regulation? With the new European MDR and IVDR regulations at the forefront of every conversation across the medical device industry, the emerging UK regime may have been overlooked as another pending compliance challenge. Yet, the UK’s exit from the European Union (EU) has brought with it a whole host of new regulatory requirements that manufacturers will need to implement if they wish to continue selling their products on the UK market. The Medicines and Healthcare products Regulatory Agency (MHRA) have issued their delivery plan for the UK’s future regulatory framework and have recently launched their public consultation on the future of medical device regulation in the UK. But what do we know so far about the immediate impact on medical device regulation in the UK?
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post market surveillance | medical device | IVD | ROW

Canada Regulations News for Medical Devices and IVDs

In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report, which is similar to the post-market Periodic Benefit-Risk Evaluation Report (PBRER) required for pharmaceuticals in Canada. This new requirement goes into effect on 18 Dec. 2021, which is fast approaching.
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Medical Devices | EU MDR

Impact of of MDCG 2021-24 on the Classification of Spinal Implants

The recently released guidance on classification of medical devices is very concerning for manufacturers with spinal implantable medical devices. MDCG 2021-24 appears to have classified many spinal fusion devices that were previously thought to be Class IIb as Class III. This means a more intense application process, closer scrutiny from notified bodies, and a significant resource investment into reclassification.
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EU MDR

Is Your Medical Device a Well-Established Technology (WET)?

As guidance committees, manufacturers, and notified bodies continue to interpret the EU MDR, some areas remain fuzzy. Well-established technology (WET) is high on the list of definitions that are disputed as notified bodies seem to have a different interpretation than the guidance document. This puts manufacturers in the difficult position of having to decide whether a device is a WET and defending that stance to notified bodies.
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MDR | IVDR | SSCP Requirements | Safety and Performance (SSP)

Overcoming Challenges and Streamlining Your SSCPs and SSPs

In case you missed it, the latest presentation in our webinar series covers the new requirements under EU MDR and IVDR: the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP), respectively. It’s no surprise that manufacturers are finding it challenging to produce these reports because they are completely new to everybody. 
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MDR | Clinical Evaluation Report

What Are Clinical Benefits and How Do You Evaluate Them in Your CER?

The rollout of the EU MDR has created new challenges for medical device manufacturers, including those that have had devices on the market for a long time. One area of increased focus is the need to quantitatively establish the clinical benefits to patients from the device based on relevant and specified clinical outcome parameters. This requirement is being strictly enforced by notified bodies and, although this can be straightforward for some types of devices, for others, it can be difficult to define the benefits to the patient.
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IVD | IVDR

Facts & FAQs: European Commission Proposal for Amendment of the IVDR (EU) 2017/746

Background The COVID-19 pandemic has led to unprecedented challenges for the In Vitro Diagnostic Regulation (IVDR) implementation impacting both manufacturers and key European Union (EU) infrastructure. On one hand, manufacturers were faced with staff shortages impacting their transition efforts and have largely shifted their focus towards the development of COVID-19 assays to fight the pandemic. At the same time, key infrastructure such as Notified Body (NB) designation, EU Reference Labs, and EUDAMED has experienced significant delays - only six NBs are designated to the IVDR, and some are at capacity already and will not take new clients. This scenario threatened significant disruption to the supply chain – the majority of IVDs under the current IVD Directive will require NB assessment under the regulation and failure to secure an assessment by May 2022 would lead to previously self-declared products coming off the market in the next seven months. Only 5% of the IVDs needing a Notified Body certificate by May 2022 have actually been granted one under this timeline. With 70% of every clinical decision being based on diagnostics, several stakeholders including NBs, healthcare professionals and patient groups expressed their concerns about a potential collapse of the healthcare system and called for urgent action. This resulted in a proposal from the European Commission on 14 Oct 2021 to review transitional provisions in the IVDR and establish a progressive roll-out. In this blog, Carlos Galamba, RQM+ IVD Director, provides the key points to be aware of in the European Commission proposal and answers the most commonly asked questions we received so far. Carlos was a leader in IVDR implementation in his role at BSI through September 2021, where he supported and led IVDR Notified Body designations, was responsible for the development of clinical procedures, technical guidance for BSI reviewers, and consulted on MDCG draft guidance prior to publication including, for example, IVD batch verification, summary of safety and performance, IVD classification rules and performance evaluation for SARS-CoV-2.
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Quality Management System | post market surveillance

Integrating Post-Market Surveillance Into Your QMS

Now that medical device manufacturers have begun to implement MDR-compliant post-market surveillance (PMS) systems, it is a good time to take stock of common areas of difficulty and inefficiency, and consider how best to address these. Even manufacturers who are continuing to place their devices under extended MDD certification have been required to comply with MDR post-market requirements since May this year.
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team members | IVDR

Carlos Galamba Joins RQM+ as IVD Director

RQM+ is excited to announce the addition of Carlos Galamba as IVD Director after several years working for one of the largest Notified Bodies leading a global IVD team and assisting in the IVDR transition efforts.
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post market surveillance | MDR

Post-Market Surveillance: A Concise Overview of Requirements

Following the May 2021 deadline, medical device manufacturers now have an MDR-compliant post-market surveillance (PMS) system in place. However, there are still many issues and questions around this topic which need addressing.
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MDR | IVDR

Top 10 Tips on How to Write a PMS Report and PSUR Without an Official Guidance Document

Manufacturers have relied on guidance from the Medical Device Coordination Group and similar organizations to interpret many of the new regulations under EU MDR and IVDR. However, guidance has not been provided for every aspect of the regulation, and application deadlines have not shifted, leaving manufacturers struggling to understand precisely how to be compliant.
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team members

Dr. Andrew Tarnaris Joins RQM+ as Medical Director

RQM+ is excited to announce the addition of Dr. Andrew Tarnaris as Medical Director. With a background as both a medical doctor and notified body clinical expert, he represents an excellent example of our unique combination of clinical and regulatory experience.
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IVD | IVDR | COVID-19

EU Update: SARS-CoV-2 In Vitro Diagnostic Medical Device Performance Evaluation MDCG Guidance Published

A new guidance document (MDCG 2020-21) has been published on the 3rd of August by the Medical Device Coordination Group (MDCG) pertaining to performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices. This document provides extensive details on what is expected for SARS-CoV2 IVDs and is envisaged to form the basis for common specification to be adopted in coming months. Even if you are not making SARS-CoV-2 assays the testing details and sample sizes outlined in the guidance provide insight on the IVDR impact to technical documentation and Performance Evaluation Reports (PERs) and provide a glimpse into the level of evidence required.
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MDR | Clinical Evaluation Report

RQM+ MDR Clinical Evaluation Roadmap: An Interview with Dr. Jai Kutty

The introduction of MDR caused a major transformation in the medical device industry. Manufacturers continue to grapple with all elements of compliance, but clinical evaluation presents unique challenges. RQM+ is committed to helping clients navigate these challenges with former notified body leaders who understand what reviewers are looking for when evaluating clinical evidence.
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News

Join us at the 2021 RAPS U.S. Convergence

30 August 2021 It is that time of year again for RAPS Convergence and we cannot wait to join the largest annual gathering of regulatory professionals from around the world. The conference will be held virtually this year from 12-15 September 2021 and we will be joining in the fun with a Q&A style speaking session and a booth featuring premium expert content from this year. Learn more about our session, booth, and giveaway below and we hope to see you at RAPS Convergence in September!
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News

RQM+ Announces Investment by Linden Capital Partners

Investment to Accelerate Growth and Expand Consulting Services for Medical Device and Diagnostics Manufacturers
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EU MDR

RQM+ Case Study: Effective Managed Outsourcing for EU MDR

THE PROJECT A leading global company offering medical technology, services, and solutions engaged RQM+ to help four business units prepare for the EU Medical Device Regulation (MDR). Specifically, RQM+ is focused on assessing and remediating gaps in MDD technical files and building compliant MDR technical documentation files for submission.
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COVID-19

Crisis Survival Tip #3: Nurture Employee and Client Relationships

The past year was an extraordinary one and gave us plenty of food for thought, whether personally or professionally. At RQM+, we have been thinking about the leadership lessons we learned – RQM+ Executive VP, Lisa Casavant, recently wrote about how we managed to hold on to our employees, and RQM+ President, Maria Fagan, reflected on how the business continued to grow throughout the COVID-19 pandemic.
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COVID-19

Crisis Survival Tip #2: Stay Committed to a Strategic Vision

The past year has left us with many lessons about leadership during a crisis. From the very beginning of the COVID-19 pandemic, we made a clear intention to stick to our values as a company, though we knew this would not be a straightforward path. RQM+ EVP, Lisa Casavant, recently wrote a post about how we prioritized the retention of our people. We’re pleased that we made this decision since we were in a much better position once demand recovered.
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Safety and Performance (SSP)

An Overview of Summary of Safety and Performance (SSP) Under IVDR

EU IVDR 2017/746 includes a requirement to write a summary of safety and performance (SSP) for Class C and D IVDs. This is a new requirement that wasn’t included in IVDD. The goal of this requirement is to enhance transparency and provide adequate public access to summarized data on safety and performance to intended users, which includes both professionals and laypeople when applicable.
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COVID-19

Crisis Survival Tip #1: Hold On To Your People

As we continue to cope with the after-effects of the COVID-19 pandemic, we’ve been reflecting on the past year and how we survived as a business. Though every company should be prepared for the unexpected to happen, it is difficult to anticipate an event on the scale of a global health crisis. At RQM+ (then R&Q), we were very determined from the very beginning to preserve our values, and we’re gratified that this approach paid off. This post is part of a series sharing how we addressed some of the challenges brought about by the pandemic.
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IVDR

[Webinar] Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance

The latest addition to our webinar series covers the biggest challenges in IVDR compliance. With hundreds of MDR submissions under our belts and a number of clients who have already received findings from their IVDR applications, we have learned a lot about the regulation, the guidance that surrounds it, and what notified bodies expect to see.
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medical device recall management

RQM+ Quick Guide to Medical Device Recall Management

Medical device recalls are daunting in many ways—manufacturers dread them, competitors love them, and patients don’t always understand them. A medical device recall could be a response to patient safety concerns or to unanticipated negative trends. All manufacturers should assume it will happen at some point and do as much as possible to be prepared for it in advance.
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Design History File

How to Prepare a Design History File for FDA Inspection

Food and Drug Administration (FDA) inspections are stressful, especially if your documentation isn’t audit-ready. Creating and maintaining a compliant design history file (DHF) will help ensure that when the time comes, you’ll be ready for an FDA inspection that results in minimal findings.
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IVD regulatory

A Comparison of IVDR to FDA IVD Regulatory Submission Requirements

The European Union’s new In Vitro Diagnostic Regulation (IVDR) May 2022 implementation date is fast approaching. If you sell IVDs in multiple markets, it may be challenging to determine the differences between the IVD regulations in the U.S., the existing IVDD, and the new IVDR. It’s not surprising that global IVD manufacturers are finding it challenging to keep it all straight.
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MDR | EU MDR

The EU MDR Date of Application Has Arrived!

The European Union (EU) Medical Device Regulation (MDR) 2017/745 date of application is here! To celebrate the incredible effort medical device manufacturers have put in so far to get to this point, we have compiled a brief review of the remaining EU MDR timeline and a list of brand new educational content brought to you by RQM+ subject matter experts. 
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MDR | EU MDR

Optimizing your Technical Documentation to reduce NB review time and questions (Medical Devices and IVDs)

Whether you are used to working with a notified body or the MDR/IVDR requirements no longer allow you to self-certify and it’s all new to you, it is more important than ever to optimize your technical documentation. Notified bodies are already swamped with MDR submissions, and as the IVDR deadline approaches and new manufacturers engage them, the bottlenecks will get even tighter for IVD NBs.
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CE Marking

How to Obtain CE Marking Under the MDR

In the EU, CE marking is the system used to demonstrate that products meet the region’s requirements for safety, health, and environmental protection. When a product is labeled with the CE marking, it can be freely traded in the European Economic Area (EEA) without restrictions. 
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IVDR

Join the RQM+ IVDR Session During RAPS Euro Convergence 2021

We are excited to host a panel discussion during next week's virtual RAPS Euro Convergence 2021! Join our expert panel for our session on IVDR Implementation Best Practices and Challenges. See the schedule here and find more details on our session below.
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medical device single audit program | ISO Standards

Everything You Need to Know About the Medical Device Single Audit Program (MDSAP)

Maintaining regulatory and quality compliance across multiple markets is challenging. In addition to meeting stringent regulatory requirements, manufacturers must also submit to regular quality system audits. When operating in multiple markets, this often means a busy audit schedule that can distract from daily operations.
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iso standards for medical devices | ISO Standards

Quick Guide to Medical Device Standards: ISO Standards and Beyond

In the regulatory world, standards are essentially recommended processes that have been developed by subject matter experts with the aim of describing the best possible way to meet an end goal. For example, quality management standards are designed to improve efficiencies and avoid product failures.
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iso 14971

ISO 14971: 2019: 3 Key Changes from ISO 14971: 2007

As the underlying risk management process for medical devices, the ISO 14971 standard is a critical component of regulatory and quality compliance. When new versions are released and harmonized, it’s up to manufacturers to learn about the changes to update systems accordingly. However, there is often a gap between the time a new version is released and when regulatory organizations require compliance.
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PSUR periodic safety update report

How to Create a Compliant Periodic Safety Update Report (PSUR) Under EU MDR and EU IVDR

The requirement for a periodic safety update report (PSUR) or post-market surveillance report (PMSR) is new under EU MDR and EU IVDR. MDD and IVDD had post-market requirements, but the MDR and IVDR requirements are more formal, and for most classes, these reports must be updated and submitted to notified bodies (NBs) on an annual or biennial basis. 
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regulatory submissions

Top 4 Findings from Notified Body Technical Documentation Audits Under EU MDR

As we complete regulatory submissions under MDR, we continue to learn from notified body feedback and audit findings. These lessons learned are captured and disseminated throughout the RQM+ team to build our unrivaled collective knowledge, but we also believe in sharing this valuable information with the industry. Here is what we have learned so far from notified body technical documentation audits under MDR.
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IVDR | ivdr CE marking

How to Obtain CE Marking Under the IVDR

CE marking is the system used in the EU to indicate that products meet the region’s safety, health, and environmental protection requirements. Products labeled with the CE marking can be freely traded in the European Economic Area without restrictions.
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SSCP Requirements

8 Lessons Learned After Writing the Summary of Safety and Clinical Performance (SSCP) using MDCG 2019-9

EU MDR 2017/745 includes a requirement to write a summary of safety and clinical performance (SSCP) for implantable and Class III devices. Although this is still a relatively new requirement, RQM+ has already gained valuable experience preparing SSCPs on behalf of our clients. If you’re starting the process of creating your SSCPs, this post covers the basics and some lessons learned from our own experience.
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Webinars

RAPS Webcast: PMCF User Feedback Surveys

Update: the RAPS + RQM+ webcast is now available on demand here. Understand the ins and outs of PMCF user feedback surveys by registering for two upcoming and free RQM+ webinars: April 27 – PMCF User Feedback Surveys: Practical solutions for leveraging user feedback surveys as PMCF activities under the EU MDR (60 minutes) (register here) May 18 – PMCF User Feedback Surveys: Practical Solutions, Lessons Learned, and Processes for Success (features activity to develop a survey in real-time, 90 minutes, 1.5 RAC credits) (now available on demand)
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Webinars

PMCF User Feedback Surveys

In this webinar we will provide practical solutions for leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.
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IVDR

MDCG 2020-16 Classification Guidance for IVDs

RQM+ experts summarize the MDCG guidance from November 2020, Guidance on Classification Rules for the in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, to aid IVD industry stakeholders in understanding, planning, and executing compliance to the IVDR by May 2022. The examples in the blogpost are not intended to be exhaustive of all scenarios of applicability.
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News

Dr. Jaishankar Kutty Joins RQM+

February 1, 2021 - RQM+ welcomes Dr. Jai Kutty.
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News

New Guidance: FDA Safer Technologies Program (STeP) for Medical Devices

U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document.
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Webinars

Best Practices for Scientific Database Searching

This on-demand webinar will address best practices in scientific database search techniques that can be applied in the performance of a clinical evaluation.
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News

Announcing RQM+

We are proud to announce that R&Q and Maetrics have merged and rebranded to form the world's leading medical device and diagnostics consultancy. Check out the full press release below or visit our new brand microsite at RQMplus.com
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News

Leveraging PMCF Surveys for EU MDR Compliance - Part 2

When to use Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.
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News

EUDAMED Delay Brings Little Comfort to Medical Device Companies

7 December 2020 Update: After some delays the first module of the European database on medical devices (EUDAMED) is live! Here is what you need to know about the Actor registration module, the first of six modules in EUDAMED: WHO can use this module? Economic operators (manufacturers, authorized representatives, importers, system procedure pack manufacturers) can now register. Note: United Kingdom (UK), Turkey, and Switzerland cannot yet. WHAT can they do? Obtain Single Registration Number (SRN) WHY is this important? The SRN is required to appear on the Declaration of Conformities (DoCs) and numerous other documents affecting all classes of medical devices. WHEN can they do it? If the company is located outside the European Union (EU), the authorized representative must register first but registration is open. HOW do I get started? Find the instructions, FAQs, and various supporting information on the European Commission's website here.  For R&Q clients that have been waiting to obtain their SRN to finalize their Summaries of Safety and Clinical Performance (SSCP), DoCs, and have TBDs in their technical documentation, this allows them to move forward.  >> Access On-Demand Webinar: Economic Operators - Addressing the EU MDR and IVDR requirements Originally published 21 November 2019, updated to reflect new MDR date of application:  The European database on medical devices (EUDAMED) has officially been delayed until May 26, 2022! Due to COVID-19 pandemic, the date of application of the MDR has been delayed to May 2021, though you don’t need us to remind you that is right around the corner! Fortunately, a potential delay in the database was anticipated and provisions for a delay are outlined in the regulation that can be found on the European Commission’s page on EUDAMED here. So, what does the EUDAMED delay mean? Article 123 (3)(d) lists all the derogations that occur with a delay in the database until six months after notice in the Official Journal of the European Union that the database is available. One caveat to that notice is that the sections that are delayed are those provisions “that relate to EUDAMED”, meaning that you will still need to create a Periodic Safety Update Reports (PSUR) per the EU MDR schedule even if it does not have to be uploaded into EUDAMED. The conclusion paragraph from the section on derogations points to provisions to take until EUDAMED becomes available in 2022. It points to the use of existing Medical Device Directive (MDD) communication methods and this works for registrations, clinical investigations, and vigilance reporting as those provisions are existing systems in the MDD. However, it leaves out how new requirements will be covered during the interim from the date of application of the regulation to the implementation of EUDAMED. There is no clarification offered for new elements such as the Safety and Clinical Performance Reports (SSCP) and the PSUR.
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News

Leveraging PMCF Surveys for EU MDR Compliance - Part 1

1 December 2020 - Getting started with Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.
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News

Lessons Learned: 2020 RAPS U.S. and Euro Convergence

RQM+ sponsored both RAPS U.S. and Euro Convergence conferences in 2020 and we also led and provided subject matter experts for two panel discussions. Our experts pulled together the highlights from both conferences and summarized them by category for our readers.
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News

A New Approach to Corporate Holiday Gift Giving

18 November 2020 - A challenging year makes it more important than ever to be supporting and serving our communities.
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News

Top Ten Tips and Best Practices for PMCF Surveys Under EU MDR

10 November 2020 - RQM+ experts have come up with a list of our top ten suggestions for mastering Post-Market Clinical Follow-up ("PMCF") Surveys under the European Union's Medical Device Regulation.
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News

FDA’s Tool for Assessing Medical Device Cybersecurity Vulnerabilities

28 October 2020 - October is National Cybersecurity Awareness month, so we think there is no better time to talk about FDA’s new qualified tool for assessing medical device cybersecurity vulnerabilities and why using it makes sense to help you #BeCyberSmart.
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News | Webinars | Q&A

Q&A: Economic Operators - Addressing the EU MDR and IVDR requirements

R&Q's August 2020 webinar focused on Economic Operators: Addressing the EU MDR and IVDR requirements head-on. In this follow-up blog post, our knowledgeable MDR and IVDR regulatory experts sat down to answer audience questions.
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Webinars

Integrating Risk and Complaint Management

Having strong integrated complaint and risk management processes is about more than just compliance. Watch this webinar and learn critical strategies and tactics for success. As with every R&Q webinar, all registrants will receive access to the slides and recording.
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News

Irish Notified Body Requires ISO 14971:2019 Compliance by December 2020

14 October 2020 - The National Standards Authority of Ireland (NSAI) has adopted December 2020 as the expected implementation date for EN ISO 14971:2019.
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News

A Discussion With the European Commission on Expert Panels

7 October 2020 - A short conversation with the European Commission provides details on when we can expect access to their expert panels. 
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News

What You Need to Know About the UK's New Medical Device Guidance

1 October 2020 - As the end of the BREXIT transition period nears, the UK government has released a proposed regime on the regulation of medical devices.
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News

R&Q Acquires Maetrics to Form the Largest Medical Device-Focused Global Regulatory and Quality Consultancy

We are proud to announce that we have acquired Maetrics, a leader in life sciences quality and regulatory consulting. Check out the full press release below or visit our RAPS Convergence 2020 announcement page for more information.
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Webinars

Program Management for IVDR and EU MDR

Whether you’re just starting to plan your IVDR program (or not sleeping well because you haven’t started yet) or well into EU MDR but ready to plan post-market surveillance activities, our September webinar will be helpful. All registrants will receive access to the slides and recording.
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News

Announcing R&Q Training Workshops

3 September 2020 - Training Workshops brought to you by the Subject Matter Experts at Regulatory & Quality Solutions.
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News

Roundup: R&Q at the 2020 RAPS Convergence

R&Q is counting down the days until we can join the RAPS community at the virtual RAPS Convergence 2020 on 13-16 September 2020. As many of you know, the Convergence is the largest annual gathering of regulatory professionals from around the world. While we'll miss interacting with everyone onsite and having fun at our exhibit booth, we're embracing this year's online format and will be doing everything we can to communicate our team's energy and expertise virtually. Thankfully, we have two can't-miss speaking sessions to help us do that!  
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News | Live!

Ranked: The most popular on-demand panel discussions from R&Q

Note: A version of this post was initially published for the flagship online publication of RAPS, Regulatory Focus™ In an effort to further support the medical device industry during the COVID-19 pandemic, we've been spreading love more than ever in one of the best ways we know how: free industry-leading education. In April, R&Q debuted a new live show: DEVICE L❤️VE Live! Webcams in, presentation slides out: The biweekly panel discussions focus on answering questions, engaging in friendly debate, sharing some laughs, and always, always... offering solutions and value. In hopes that you see a topic that interests you and aligns with your objectives, we've ranked the most popular episodes of the show to this point below. Additionally, these and all shows are also available via our Device Love Podcast.
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News

R&Q's Ruthanne Vendy Contributes to RAPS Fundamentals of EU Regulatory Affairs

11 August 2020 - We sat down to with R&Q's Ruthanne Vendy, RAC to talk about her experience as a contributing author to the Regulatory Affairs Professionals Society’s (RAPS) Fundamentals of EU Regulatory Affairs, Ninth Edition.
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Webinars

Economic Operators: EU MDR and IVDR Requirements

In our August 2020 webinar you'll learn about the EU MDR and IVDR requirements for economic operators.
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News | Webinars | Q&A

Q&A: Solving the EU MDR Labeling Puzzle

Although a lot has changed in our worlds since R&Q's December 2019 webinar focused on Solving the EU MDR Labeling Puzzle, the general requirements have stayed the same. In this blog post, our knowledgeable EU MDR regulatory experts sat down to provide some updates on a few more pieces of that labeling puzzle.
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News

First Do No Harm: Protecting Patients Through Post-Market Surveillance

15 July 2020 - R&Q experts discuss "First Do No Harm - The report of the Independent Medicines and Medical Devices Safety Review."
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Webinars

PMCF Plans

In this on-demand webinar originally presented in July 2020, find out how to create detailed, compliant, and business-balanced PMCF plans.
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News | Webinars | Q&A

Q&A: FDA Emergency Use Authorization (EUA) and EU MDR Article 59

R&Q's May 2020 webinar focused on FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for prevention and treatment of COVID-19. In this blog post, our knowledgeable FDA and EU MDR regulatory experts sat down to provide answers to your questions from the webinar and we hope that they will shed some light on similar questions that you may have on the topic.
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EU MDR

State of the Art (SOTA) Part I: What is a State of the Art Evaluation?

You have been reviewing the 4th revision of the European Commission’s Guidelines on Medical Devices, "MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC" to make sure you are following all requirements to get (or keep) your medical device on the market in the European Union (EU). The term “state of the art” is mentioned 39 times throughout the document, but what exactly does the European Commission mean by it and what are you supposed to evaluate according to the guidelines? We are glad you asked! In this two-part series, we will start by reviewing what state of the art really means in the EU’s medical device guidelines and what their objective is in using the phrase. What is state of the art? Although state of the art is commonly defined as the newest idea or newest feature, state of the art in relation to European Commission regulations for medical devices does not imply the most technologically advanced solution. First mentioned on page 9 of the MEDDEV 2.7/1 guidance document, state of the art in this context refers to the current state (or current knowledge) of comparable treatment options. Another way to think of it is by asking “what is currently and generally accepted as good practice?” Moreover, the "MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies" gives a definition of state of the art as:
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News | Webinars

Q&A: RAPS Webcast - PMS Requirements of the EU MDR

R&Q is a Premium Solutions Partner of the Regulatory Affairs Professionals Society (RAPS) and in April, we joined forces to offer up a premium webcast. R&Q Executive Director of Regulatory and Quality Consulting Services, Nancy Morrison, presented PMS Requirements of the EU MDR: Implementation Challenges and Solutions. This webinar is an extended, enhanced, and more up-to-date version of R&Q's own February 2020 webinar. This is your chance to get difference-making information from one of the industry's utmost thought leaders and apply it to your own organization. If you were not able to attend this webinar, here's a link where you can sign up to view the on-demand version (and download the slides). R&Q is here to help address any other questions that you may have regarding audits or any other Post-Market Surveillance related topics. Contact us today to find out how we can help! 
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Webinars

Developing an FDA Regulatory Strategy (Part 2)

A definitive guide for entering the US market.
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News | Webinars

Q&A: Structuring PERs under IVDR

R&Q's April 2020 webinar focused on Structuring Performance Evaluation Reports (PERs) under In Vitro Diagnostic Regulation (IVDR). In this blog post, our knowledgeable IVDR experts sat down to provide answers to your questions from the webinar and we hope that they will shed some light on similar questions that you may have on the topic.     We all know that the clock is ticking down to the IVDR date of application! May 26, 2022 sounds far away, but it's really not considering the size of the step to IVDR compliance for most IVD companies. The transition from MDD to MDR for medical device manufacturers feels relatively small in comparison to the 85% of IVD companies moving from self-certified to notified body audits, complex regulatory systems, and the expectations of much tighter controls over the web of virtual manufacturing and distribution relationships that IVD companies are accustomed to. R&Q is here to help address any other questions that you may have regarding audits or any other IVDR related topics. Contact us today to find out how we can help! Have more questions on IVDR? Join us on Thursday, June 18 for the discussion during DEVICE L❤️VE Live! #10 Transition to IVDR: How far along should we be? Click here to learn more and register for free. If you were not able to attend this webinar, here's a link where you can sign up to view the on-demand version (and download the slides).  
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News | FDA | EU MDR

Emergency Use Authorization Stories: The Humn Project

As we collectively watch the world struggle to cope with the devastating impacts of COVID-19, the Emergency Use Authorization Act has given the R&Q team opportunities to provide pro bono regulatory guidance to incredible medical device companies that are prioritizing “giving back” to the communities that desperately need the help. --------- The Humn Project During our recent R&Q DEVICE L❤️VE Live!, our subject matter experts discussed the use of the U.S. Food & Drug Administration’s (FDA) Emergency Use Authorization (EUA) process and E.U.’s Medical Device Regulation (MDR) Article 59 to release medical devices needed for the COVID-19 Public Health Emergency.  Check out the on-demand recording of this show here. The U.S.’s EUA allows medical devices that are uncleared or unapproved by the FDA to be used during a national health emergency, in this instance to help prevent the spread of COVID-19. The EUA process is enabled by a Declaration of a Public Health Emergency by the U.S. Department of Health & Human Services (HHS). This process allows for manufacturers of necessary medical devices, in vitro diagnostic devices (IVD), and pharmaceuticals to request an expedited and interactive EUA review to address unmet needs during a health emergency, as we have seen at the global scale during the current COVID-19 pandemic.  This is where Daniel Clark, President of Linear Health Sciences, an Oklahoma-based medical device company and a longtime client of ours, comes in. Typically specializing in the development of products for various types of medical tubing based on proprietary, breakaway safety-valve technology, Clark partnered with his twin brother and younger sister to found the benefit organization, The Humn Project, to develop a UV-C disinfectant light to combat the spread of the devastating virus with a focus on human safety while using the device. “Thanks to the incredible work R&Q has led, we're in a great position currently looking forward to making a fundamental impact on the war against this invisible enemy.” – Daniel Clark, The Humn Project When R&Q heard that Clark and his team were working to bring an open-source, not-for-profit medical device to help prevent the spread of COVID-19 through the EUA, we knew we had to use our team’s expertise to help their efforts at no expense. To assist the project, our team developed a Regulatory Strategy for the device's EUA submission to support labeling and testing plans by compiling and drafting the pre-EUA submission, serving as Regulatory Correspondent with the FDA, and planning to compile the EUA submission in the near future.   We are proud to support remarkable organizations like Humn Project because it is in R&Q’s blood to want to improve the lives of others and we love to back people making a difference in our communities. As Andrea Clark, Marketing and Commercial Partner of Humn Inc., stated: “Humn Project was built out of this need to strengthen public health by building essential products to benefit society at-large. With no other competing interests, Humn Project recognizes inherent disparities within public health and we are working to even the playing field. Currently, this work includes a novel FAR-UVC disinfectant lamp that reduces the spread of germicidal spores. Working with multiple partners, from engineers and testing experts to the R&Q Regulatory experts, we are expediting our MCM through EUA to get this into clinical essential workers’ facilities as quickly as possible." By providing pro bono regulatory support with the EUA process to obtain FDA authorization for Humn Project, R&Q hopes to support its incredible mission and get the device to market quickly and safely. Brian Clark, Humn’s Managing Partner, reiterates the urgency of getting this technology into the hands of those that need it: "Our mission at Humn is to create open-source technology-driven solutions that positively impact communities with efficient scale. We are a benefit organization, and our first opportunity is to commercialize the promising research on the use of Far-UVC as a germicidal disinfectant. Unlike traditional germicidal UV lamps, research indicates this form of UV light can destroy viruses and bacteria, yet still operate safely around humans. The Far-UVC product that we're bringing to market provides direct support for our communities and front-line workers, and benefit the broader health outcomes of our communities." Want to learn more about this topic? Join us on Tuesday, May 26 for R&Q’s May Webinar on the FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for the prevention and treatment of COVID-19. In this free webinar, we will discuss both emergency application processes, provide answers to the many questions we have received, and share tips and lessons learned from our experiences. Click the button below to learn more and register: If you are looking for help with EUA or other regulatory needs, check out our Regulatory Services page here and contact us today! Our remarkable remote support team is available across all R&Q services and we're ready to answer any questions or concerns you have about how to stay on track for the EU MDR timeline. We can help you navigate the difficult road ahead and we have ample virtual content to keep you in the know. Source: FDA Emergency Situations Medical Devices. Accessed 11 May 2020. https://www.fda.gov/medical-devices/medical-device-safety/emergency-situations-medical-devices. 
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Events | Webinars

FDAnews Webinar featuring R&Q's Jon Gimbel, Ph.D. on June 2

Tuesday 2 June 2020 — An FDAnews Webinar featuring R&Q
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Webinars

Case Studies of MDD and MDR Audit Findings... and Lessons Learned

On-Demand - A webinar entirely dedicated to case studies.
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News | EU MDR

RQM+ Remediation Station: Tools & Tips

Welcome to the Remediation Station! We've got live shows with the experts, case studies, and insights to help you get through remediation successfully.  First up, join us Friday, May 8 11:00am ET / 8:00am PT for Device Love Live #4: Best Practices for Reducing Pain in a Medical Device Remediation Program. Our subject matter experts are talking about remediation programs at medical device companies. DHF and manufacturing remediation resulting from government actions (FDA warning letters, EU's non-compliance reports) are the extreme and we know that the proactive efforts needed for many companies to achieve MDD compliance let alone the jump to MDR are no piece of cake either.   Remediation often exhausts the team, brings down morale, and leads to much debate over what is "good enough".  Let's talk about best practices to enable remediation efforts to be as pain free as possible. Join us for free by clicking the button below: Keep reading for more insight on the remediation process and what your company can do to improve your success: When do medical device companies need remediation? The need for remediation efforts at a company can be generated for a multitude of reasons. Most often it is the result of an FDA inspection or Notified Body audit that has identified numerous non-compliances. Preferably, internal audits identify areas to focus on proactive remediation efforts to avoid regulatory body findings. Established device companies typically have known deficiencies that need to be rectified or holes that need to be patched in Design History Files (DHFs), Technical Documentation, Risk Management, or Supplier Controls to name a few. No matter where you are in the range of having new-to-the-market medical devices or long-established legacy devices, you could find yourself in the situation of needing to remediate.  >> Click Here to Read a Case Study: Revamping Supplier Quality Remediation So, remediation is needed - now what? The key to successful remediation is to strategically plan your organization’s efforts. Whether remediation is conducted for proactive or reactive reasons, the tasks to address these regulatory compliance issues can be daunting. To properly achieve an effective resolution, these efforts can require numerous resources and time, potentially disrupting new product development and current operations. Most companies do not have the capacity to plan and execute remediation activities on top of the existing day to day work. We are seeing firsthand the significant resource drain and impact throughout Regulatory, Quality, and New Product Development functions at many device companies created by remediation efforts on legacy device DHFs to achieve EU Medical Device Regulation (MDR) compliance. Not conducting thorough remediation could lead to delays in your MDR certification or, in some cases, being forced to withdraw your device from the EU market. The good news is that R&Q has experts ready to go to help you successfully achieve compliance. How R&Q can help you achieve your goals Your company may have remediation experience and a strong team, but due to tight response deadlines and capacity constraints, you are struggling to adequately support the remediation effort. On the other hand, you may be going through this type of activity for the first time. R&Q’s expertise can help to drive forward any aspect of your remediation efforts. Our adaptive team can provide: >> Click Here to Learn More About R&Q's Remediation Services  Remediation Project Management - essential planning and oversight of remediation from beginning to end. Experienced Resources - our knowledgeable and experienced team members have conducted remediation efforts across many companies and types of medical devices. R&Q can support your efforts on-site or fully remote, freeing up internal resources to continue their much-needed daily operations. Subject Matter Experts – don’t have the knowledge to address issues in-house? R&Q has the expertise to guide you. Having outside eyes to review can help to identify some glaring issues and creative solutions that may not be apparent internally. Collaboration and Ownership - R&Q has a proven track record of integration into client teams to help effectively drive remediation. This collaboration ensures the effort is not just an outside entity coming in and making changes in your company. R&Q works hand in hand with our clients throughout the process to assure business agreement and ownership. Sustainable Robust Resolutions – not just stop the leak and move along …thorough investigation and gap/risk assessments to identify root causes and precise resolutions. The R&Q team will identify the issues and root cause and then work with you to make the appropriate robust changes needed to achieve compliance and avoid reoccurrence. Long Term Assurance and Support – R&Q assists in long term compliance assurance by providing periodic Internal Audit services, as well as mock audits conducted by former FDA or Notified Body auditors. R&Q can also provide appropriate training needed for internal client employees regarding compliance, regulatory requirements, and audit preparation. Regulatory & Quality Solutions (R&Q) provides best practice strategic and tactical solutions to tackle your remediation challenges. Specializing in the United States (US) and European Union (EU) regulatory and quality environments, our team can help your medical device company successfully address deficiencies and remediation efforts related to: Notified Body non-conformity reports MDD to MDR Compliance EU Technical Documentation FDA Consent Decrees, 483 Findings, and Warning Letters Complaint / Adverse Event and Device Reporting Corrective/Preventative Action Plans Internal Audit Findings Design History Files (DHF) Risk Management Programs Supplier Quality Control The R&Q team customizes the level of support needed for your remediation efforts. Whether you need a small audit or a full team to support large scale remediation, R&Q can help every step of the way. Have questions about remediation? Contact us today and check out our remediation services page for more details on how we can help.
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Live!

DEVICE L❤️VE Live! #5 — 5/14/20

Chatting with Former FDA and Notified Body Representatives
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News | EU MDR

R&Q Experts Reviewed the New MDCG Guidance - Here is What They Learned.

If you were excited when the European Commission finally released four guidance documents covering Clinical Evaluation Equivalence, Clinical Evidence of Legacy Devices, and templates for the Post-market clinical follow-up (PMCF) Evaluation Reports and Plans (MDCG 2020-5-8) last week (23 April 2020), you were not alone! Many of us have been waiting in anticipation for further guidance on how to handle PMCFs and were anxious for further clarification on the expectations of medical device manufacturers in this area. Our team looked into the guidance right away in hopes that we could find some clarification for our clients. As one of our experts put it, however, on the surface this guidance is “clear as mud”. So, we dug into the new guidance and made a table to help make connections for the industry. A few of our overall observations are listed here and check out the table below to dig deeper into each section. • The biggest challenge we see is that because this guidance came so late in the cycle, many manufacturers have been trying to figure out how to comply and move forward for some time now. This leaves many organizations wondering how to use what they have already done and apply the guidance to their completed work. • Additionally, there is continued ambiguity around what to do first, further proving that this is a continuous process and not a linear process. So, where do you start? • We would have liked to see more discussion around risks and benefits regarding the guidance for legacy devices, or better direction pointing manufacturers to the best way to take ownership of this area. • One upside we found is that there is a table for legacy devices that provides a hierarchical appendix for ranking PMCF activities, which is incredibly helpful. Here is a tip from our pros: FDA guidance can be helpful in deciphering the expectations especially around risk-benefit analysis.   REFERENCE TITLE GOOD NEWS WATCH OUTs NOT SURPRISING WAS THIS REALLY NECESSARY? MDCG 2020-8 Guidance on PMCF Evaluation Report Template - The administrative section is a direct copy from the administrative section of the PMCF plan. - You must declare if your device is novel or not; this should match your technical documentation - You need your CND codes; if you haven’t done these yet, it is time - The data from similar devices is required and must include an assessment if this impacts state of the art, identifies new hazards or impacts benefit risk analysis - You need to specifically define how the PMCF report impacts the CER or justify why it doesn’t - You need to specifically define how the PMCF report impacts the risk management or justify why it doesn’t - You will need to include common specifications, harmonized standards and guidance documents utilized for the product; Make friends with Regulatory since they have to do that in the technical documentation MDCG 2020-7 Guidance on PMCF Plan Template - The administrative section is a direct copy from the administrative section of the PMCF plan. - You must define explicitly where the PMCF activity need is coming from (Notified Body request, CER, Risk Management, etc.) - You need to review case reports that may reveal off-labeling usage or misuse as part of PMCF - You need your CND codes; if you haven’t done these yet, it is time - The data from equivalent and similar devices are required and must include an assessment if this impacts state of the art, identifies new hazards or impacts benefit risk analysis - The general and specific methods and procedures PMCF activities need to be included with aim, appropriateness of methods, limitations, and endpoint/deliverable schedule - You need to specifically define how the PMCF plan impacts the CER and risk management report or justify why it doesn’t - You will need to include evaluation of similar and equivalent device clinical data, including CER location in text references and how this data will be used (must match technical documentation) - You will need to include common specifications, harmonized standards and guidance documents utilized for the product MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices - The definitions section includes terms that may not have been defined explicitly in the MDR, expands upon terms and cites where the definitions were derived (MEDDEV 2.7.1 Rev.4, etc.), especially on what “well-established technologies” can include. - Examples of validated clinical data methodological quality assessment tools are provided - Appendices contain modified Clinical Evaluation Plan for Legacy devices and a suggested hierarchy of clinical evidence for confirmation with relevant GSPRS under MDR, depending on the device—a lower level of clinical evidence may be justified - During the period of validity of the MDD/AIMDD certificates, the MDR requirements for the PMS apply from the MDR date of application-- Legacy devices are not exempted from the additional requirements in MDR concerning PMS, including PMCF - Changes in the state of the art, new risks identified via PMS, clinical evidence of devices not sampled prior to application of MDR may not have had Notified Body scrutiny, and more detail required for indications and contraindications may change the clinical evidence needed - Clinically relevant endpoints may be addressed through compliance to product-specific common specifications (device and sufficient clinical data-dependent) - Clinically relevant questionnaires used to bridge gaps with MDR requirements should be scientifically sound and the guidance includes minimum considerations - The MDR has new requirements for equivalence and clinical data, which may reduce data available for demonstration of conformity with GSPRs - You need to conduct a gap analysis for legacy devices per MDR GSPRs, if you have not done so - You need to establish or update a clinical evaluation plan - Compliance to nonclinical common specifications relevant to device safety and performance need to be referenced depending on the device type and sufficient clinical data (these may need to be reference in the PMCF plan and PMCF report) MDCG 2020-5 Guidance on Clinical Evaluation – Equivalence - Differences in equivalence criteria (technical, biological, and clinical characteristic) between MDR and MEDDEV 2.7.1 Rev. 4 delineated and includes explanatory text. - Example considerations of an equivalence characteristic table is included in Annex I (Note: this is not an exhaustive list) - Proper scientific justification for equivalence is needed --devices must have no clinically significant difference in safety and performance between the equivalent and device in-question when used under similar conditions -OR- a description of safety and clinical performance impact must be provided that must be justified. - Clinical data that does not meet the MDR definition cannot be used as clinical evidence to conform with relevant GSPRs. - Pre-clinical data considered for equivalence demonstration should adequately evaluate technical and biological characteristics, and whether differences would result in a significant difference in safety and clinical performance - For products without an intended medical purpose, clinical investigation should be performed unless reliance on existing clinical data from an analogous device is justified—using demonstration of equivalence, demonstration of clinical benefit, compliance to any product-specific common specifications, and demonstrating no clinically significant difference in safety and performance between the devices. - The MDR biological characteristics require assessment of the final product to include factors such as processing or - Principles in ISO 10993 standards can be adopted depending on the biological evaluation necessary for the device. - Equivalence claims cannot be made if a manufacturer cannot demonstrate sufficient access to the presumed equivalent device - Similar device data can be used for risk management (design hazards, clinical risks, adverse events, and acceptable occurrence rates), state of the art, clinical investigation/ PMCF study design, definition of minimum required quantified clinical benefit - Compliance to nonclinical common specifications relevant to device safety and performance need to be referenced depending on the device type and sufficient clinical data (these may need to be reference in the PMCF plan and PMCF report). Make friends with Regulatory since they have to do that in the technical documentation. Have questions? Our remarkable remote support team is available across all R&Q services and we're ready to answer any questions or concerns you have about how to stay on track for the EU MDR timeline. We can help you navigate the difficult road ahead and we have ample virtual content to keep you in the know. Source: European Commission. Docs Room. Clinical Evaluation Equivalence, Clinical Evidence of Legacy Devices, and templates for the Post-market clinical follow-up (PMCF) Evaluation Reports and Plans (MDCG 2020-5-8). Accessed 30 April 2020. https://ec.europa.eu/docsroom/?locale=en 
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News | Webinars

Q&A: EU MDR Audits: Preparing, Managing & Responding to Nonconformances

R&Q's March 2020 webinar focused on dealing with EU MDR Audit Nonconformances. In this blog post, our knowledgeable EU MDR experts sat down to provide answers to your questions from the webinar and we hope that they will shed some light on similar questions that you may have on the topic. This is only a small sample of the questions that manufacturers currently have around EU MDR audits - and there are sure to be countless others! R&Q is here to help address any other questions that you may have regarding audits or any other EU MDR related topics. Contact us today to find out how we can help! If you were not able to attend this webinar, here's a link where you can sign up to view the on-demand version (and download the slides).
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Webinars

FDA Emergency Use Authorization (EUA) and EU MDR Article 59

26 May 2020 - Processes, tips, and lessons learned.
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MDD | News | EU MDR

BREAKING NEWS: European Parliament Approves One Year EU MDR Delay

This post is an update to our recent blog post where Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shared her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline. You can read that post here.
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Quality Management System | News | ISO 9001:2015

Focusing on Process Improvements as a Competitive Advantage

At R&Q, we are seeing firsthand how heavily impacted companies of all sizes are by the volatile global markets brought on by the COVID-19 pandemic. To assist our country’s more vulnerable businesses, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed in March, thereby permitting the U.S. Small Business Administration’s (SBA) to initiate the Paycheck Protection Program (PPP). What better use of this program than to spend this time having employees “Sharpening the Saw” while simultaneously gaining a competitive advantage by focusing manpower on improvements and working toward ISO 9001:2015 Quality Management Systems implementation. For some companies, production levels are at a record-breaking high, where others have come to complete halt due to a lack of demand and help is needed now to provide employees with security during the next few months. You should be looking for ways to embrace Stephen Covey’s principle of “Sharpen the Saw”! Companies looking to capitalize on the program can utilize the economic downtime to conduct some “self-care” upon the internal structure of your business. This approach allows your company to maintain a level of employee engagement, while also driving initiatives that will build a competitive advantage within your industry. Now is the time for your company to improve your business processes and bottom-line long term. We recommend strongly considering the immense benefits of implementing the internationally recognized ISO 9001:2015 Quality Management Systems (QMS) program. This program will provide a structured approach to help your team identify critical business processes, document, improve, apply metrics and enable management measurements. The best benefit of implementing this system is, above all, efficiency. Eliminate the areas of your process that cause mistakes, delays, and inefficiencies by training your team on the globally accepted ISO 9001:2015 approach. Do not overlook the opportunity to reengage the workforce on these initiatives – who better to utilize than the small army that you have amassed and trained to understand, build, deliver and/or maintain your product or service? Take the time to reflect, understand and improve your business’ processes and procedures and how they interact throughout the company, in turn leading to increased productivity and improving your bottom line. When the quarantine orders are lifted and your customer orders are piling, you will be steps above the competition with your ISO 9001:2015 Quality Management Systems training in place and ready to make your customers thrilled! Some focal process improvement areas that can be capitalized on are: • Understanding where processing bottlenecks restrict maximizing throughput • Identifying the hidden “rework loops” that are costing extra time and materials • Looking for misaligned or out of control processes that waste raw materials • Conducting past due maintenance to prevent unnecessary downtime Some successful quality methodologies to train upon to maintain positive results: • Value Stream and Process Control Mapping • Design and Process Risk Management • Lean / Six Sigma / 5S Philosophies If you aren’t quite sure where to start or currently do not have the expertise on hand to drive such initiatives in a short time – then do not hesitate to contact R&Q today. We are experts at remote Quality Management and Process Improvement and would love to answer your questions! We can partner with you in excelling your business through: • Customizing a business-balanced approach to full ISO 9001:2015 Quality Management Systems implementation. Any QMS initiative should remain flexible to drive a strategic vision while retaining a positive culture, continual improvement, and factual decision making. • Customizing the facilitation of process enhancements to achieve consistency of a product or service provided and reducing the “decoupling effect” where the established process no longer adequately supports real-time operations. Process gap analysis and data analytics can assist with reengineering procedural concepts and documentation to compliantly realign expectations to real life. • Customized quality initiative training either to support a full ISO 9001:2015 Quality Management Systems implementation or select quality management concepts to assist in driving a quality-minded culture. You can learn more about our Quality Systems services here. Stay safe and productive everyone! We have many free virtual events in the works for this week and beyond! Check them out here and be sure to join us on Friday, April 17 for our first ever DEVICE L❤️VE Live! A new weekly and interactive live show featuring expert panelists discussing hot topics, challenges, and solutions in the medical device industry. This episode will focus on moving medical device manufacturing out of China. Click the button below to learn more and register for free!  As always, R&Q experts are here to help you navigate the difficult road ahead with ample virtual content and remote experts on hand so don't hesitate to reach out to your R&Q representative and contact us today.
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MDD | News | EU MDR

COVID-19 Continues to Impact Medical Device Manufacturing in China

Medical device companies often have a globally distributed workforce which can include remote specification developers and, more likely, manufacturing sites. In China alone, where the virus was first detected, many medical device companies have manufacturing sites, utilize contract manufacturing sites, and get medical device components – all in China. The disruption in this supply chain will impact device companies and can delay getting devices to customers which can negatively impact healthcare. Realizing the potential impact on manufacturers’ supply chains, the United States Food and Drug Administration (FDA) issued a “Coronavirus (COVID-19) Supply Chain Update” on February 27, 2020 detailing how they are monitoring the medical device industry dealing with the COVID-19 outbreak. To monitor potential impacts including shortages of drugs and medical devices the FDA has set up an email box, deviceshortages@fda.hhs.gov, to enable medical device manufacturers can report shortages. A major concern that has arisen during the COVID-19 crisis is the lack of ventilators available in the US healthcare system to aid COVID-19 patients. To help manufacturers dealing with supply chain shortages of ventilators the FDA issued the policy guidance, "Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency". The FDA hopes that this policy change will create more flexibility for manufacturers that must make device modifications to address current manufacturing limitations or supply shortages. Per the policy, changes to the devices that would normally require a 510(k) will not need to have one submitted for the duration of the public health emergency. Manufacturers must validate the changes to their device and document the change in their device master record and change control records. The policy guidance also describes the FDA's intended approach to Emergency Use Authorizations (EUA) and provides a website and the information requested by FDA to make their determination as to whether an EUA can be issued. Manufacturers who are not currently engaged in medical device manufacturing may also submit for an EUA. FDA intends to work collaboratively with these manufacturers to get through the EUA process.  For example, Ford Motor Company announced recently that it is joining forces with medical device manufacturers including 3M and GE Healthcare to quickly expand production of urgently needed medical equipment and supplies for healthcare workers, first responders, and patients fighting COVID-19. Device manufacturers are also making a positive impact during the crisis by developing diagnostic tests for COVID-19. Multiple In Vitro Diagnostic (IVD) manufacturers are working to develop COVID-19 tests and there are currently multiple test kits on sale that have been made available under CLIA waivers and EUAs with additional testing kits under development. The FDA has relaxed its requirements for CLIA-certified labs and is allowing them to use their test kits without needing to have Emergency Use Authorization. However, the CLIA labs do need to submit an Emergency Use Authorization application within 15 days of validating their new test.[1] BioFire, a division of bioMerieux, has received an EUA from the FDA for a COVID-19 test kit, and Mesa Biotech has received an EUA for their Accula device which is designed to allow for near-patient testing with the results in about 30 minutes[2]. Interested in learning more about this topic? Join us on Friday, April 17 for our first ever DEVICE L❤️VE Live! A new weekly and interactive live show featuring expert panelists discussing hot topics, challenges, and solutions in the medical device industry. This episode will focus on moving medical device manufacturing out of China. Click the button below to learn more and register for free!  As always, if there are questions on the guidelines ask your Notified Body (NB). R&Q experts are here to help you navigate the difficult road ahead with ample virtual content and remote experts on hand so don't hesitate to reach out to your R&Q representative and contact us today.
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News | Events | Live!

Join Us Weekly — Announcing DEVICE L❤️VE Live!

The current pandemic is challenging for everyone to varying degrees. R&Q has the utmost respect, appreciation, and love for healthcare workers and all frontline workers across the globe. Our mission from the start has been to improve people's lives and our announcement today has regulatory and quality medical device professionals in mind. There is no better time than now for all of us in and connected to the healthcare industry to be at our best for patients requiring medical care and the healthcare workers providing it. Along with rallying around one another for support, sharing and discussing the latest industry news, regulation changes, pressure points, and potential solutions to problems can be invaluable for us all. Actual solutions are obviously important and our company name isn't Regulatory & Quality Solutions by chance! Those of us not on the frontlines and practicing social distancing (the majority of regulatory and quality pros we know) are also craving connection. FaceTime, Zoom, Houseparty, or whatever your app of choice for connecting with family and friends is great, but what about all those cancelled conferences and networking events? We still need to connect with and learn from each other professionally. For all of those reasons and following in the footsteps of our monthly webinars (which will continue), we're excited to announce a new live and interactive weekly show: DEVICE L❤️VE Live! Show #1 will be next Friday, April 17th. How will it go? Each show will center around a specific newsworthy topic and bring together experienced thought leaders on camera to discuss it. For example, next week we'll discuss moving medical device manufacturing out of China. Weekly topics will be chosen based on what challenges our clients are facing and what our own experts are reading about. The sessions will depend on your questions. We'll bring some client questions to the table and some of our own, but the direction each show takes will be dictated by you. Ask questions live and if fellow attendees want to see it answered by our panelists, they'll be able to easily upvote it. This brings the most popular questions to the top of the list for the moderator to ask the panelists about. Read on for more information on next week's show and subscribe to our blog to learn of the weekly topics.    
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Webinars

RAPS Webcast: PMS Requirements of the EU MDR

  Note: this webcast is now available on demand. R&Q is a Premium Solutions Partner of the Regulatory Affairs Professionals Society (RAPS) and on Wednesday, April 15th, we're joining forces to offer up a premium live webcast. Attendees will earn 1.5 RAC credits and the event is free. R&Q Executive Director of Regulatory and Quality Consulting Services, Nancy Morrison, will be presenting PMS Requirements of the EU MDR: Implementation Challenges and Solutions. This webinar will be an extended, enhanced, and more up-to-date version of R&Q's own February 2020 webinar. An hour and a half has been allotted and Nancy will be taking live questions. This is your chance to get difference-making information from one of the industry's utmost thought leaders and apply it to your own organization.
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News | Webinars

Q&A: PMS Requirements of the EU MDR

In February – just before COVID-19 began to seriously impact those of us in the United States – R&Q Executive Director of Regulatory & Quality Consulting Services, Nancy Morrison, presented the webinar PMS Requirements of the EU MDR: Implementation Challenges and Solutions. We received a ton of excellent questions during that webinar and in this blog post, we'd like to publicly share our answers to many of them. We hope you find them helpful! If you haven't seen this webinar yet, here's a link where you can sign up to view the on-demand version (and download the slides). If you have specific questions in this area, please contact us.
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Webinars

Structuring PERs under IVDR

Whether you are interested in improved strategies for completing PERs or effectively completing your first PER, our April 2020 webinar can act as a critical guide.
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MDD | News | EU MDR

How Will COVID-19 Impact the EU MDR Timeline?

Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shares her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline: Team NB, the European Association of Notified Bodies (NB) that are active in the medical device sector, released a short statement on March 12 discussing the anticipated impact of COVID-19 on the Notified Bodies. See their statement here. Per the statement, the outbreak and associated travel restrictions are affecting the Notified Bodies’ ability to conduct both Medical Device Regulation (MDR) audits and surveillance audits to existing directives. Team NB assures readers that the Notified Bodies are discussing contingency plans with the competent authorities to work through the issues ahead. R&Q Subject Matter Expert Dr. Ibim Tariah, Vice President of EU MDR and IVDR Consulting Services, says that given the ripple effect COVID-19 has already had on medical device global business capabilities, travel and the workforce, we may see an impact on the MDR timeline and especially the upcoming May 26 date of application. We see that COVID-19 is having a ripple effect through the MDR certification process and may continue to do so for years ahead. At this time, only 10 Notified Bodies (out of 56 MDD designated NBs) have been designated to the MDR to date. Additionally, COVID-19 is further reducing the European Union competent authorities’ ability to conduct the necessary activities to designate additional Notified Bodies. COVID-19 effects of travel restrictions, reduced workforce, and the lock down in Italy have enormously compounded an already challenging endeavor for the competent authorities to designate more NBs in a timely manner. As a result, a heavy workload concentrated to a small number of NBs leaves many manufacturers with undesignated notified bodies at a loss for a path and the necessary guidance to MDR certification. Current Notified Bodies certainly have the capability to conduct some audit activities remotely, but there are portions of the conformity assessment process, such as verifying manufacturing processes, that must be done at the physical manufacturing facility. There is a requirement of some amount of on-site work that is required prior to issuing CE certificates and due to social distancing measures being put in place across the globe, it is difficult to know when these necessary audits will resume. On the other hand, even if the Notified Bodies were able to travel, medical device manufacturers are working through the enormous challenges of a reduced workforce imposed by COVID-19 limitations. Of course we must mention the manufacturers that work with a critical supplier or manufacturing site in China experiencing additional barriers to successful audits – and that’s a topic that requires an entire post of its own! Despite no official word from the European Commission on an EU MDR date of application extension at this time, we believe that these external influences caused by COVID-19 may result in the reconsideration of the date of application on May 26, 2020. It will take an act of Parliament to change the date of application, advised by the European Commission which could result in another corrigenda being published, such as when Class 1R devices were delayed. In the past, we have seen other EU regulations extended or partially extended at the last minute. In 2016, for example, the EU Commission delayed the date of applicability for the PRIIPs Regulation (financial disclosure) by one year. The statement was issued November 6, 2016 extending the date of applicability until January 1, 2018, which was only seven weeks before the due date. As with so many important decisions during this challenging and uncertain time, it is difficult to predict what the extension might be, if any. A reasonable request from industry would be an extension to existing certificates in an abbreviated fashion. Currently, however, there are only rumors and no official statements from the Commission committing to such an extension. In fact, they just released new guidance this week – see our blog post here. We believe a change will be difficult and if it happens it will occur in the final hour. R&Q experts are advising manufacturers to keep working on compliance to the target dates even though the virus may be the final straw needed to push the Commission to act. In the meantime, our remarkable remote support team is available across all R&Q services and we're ready to answer any questions or concerns you have about how to stay on track for the EU MDR timeline. We can help you navigate the difficult road ahead and we have ample virtual content to keep you in the know.
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MDD | News | EU MDR

New EU MDR Guidance on Significant Changes

As most of the world seems to be at a standstill this week, the European Commission published new guidance (MDCG 2020-3) to further define “significant change” requirements under the new Medical Device Regulation (MDR) policies coming our way on May 26, 2020. The highly anticipated guidance provides medical device manufacturers and Notified Bodies (NB) with flowcharts to determine if devices currently covered by certificates under Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD) should consider a change in their medical device as significant when transitioning to MDR under Article 120(3). R&Q experts found that the new flowcharts are helpful in terms of identifying which medical devices would qualify as a significant change, though the guidance would benefit greatly by providing specific examples of changes to help interpret the flowcharts. The European Commission reiterates that no new certificates will be issued as a result of changes and that the Notified Bodies (NB) may choose to assess a change and, subsequently, issue a letter that will document that the change was not deemed a significant change. Manufacturers are then required to maintain the letter. According to the new diagrams, the EU MDR transitional provisions consider significant changes as: Chart A: Change in the intended purpose o Extension or change in intended purpose o New user or patient population o Change of clinical use (e.g. new anatomical site) Chart B: Change in design or performance specification o Needs new clinical data to support o New risks that require control measures o Change in built-in control mechanism, operating sources, source of energy or alarms Chart C: Software chart o New or major change to operating system o Modified architecture or database structure, algorithm o User input replaced with closed loop algorithm o New diagnostic feature or new channel of inter-operability o New user interface o Not a minor change Chart D: Change in material o Change includes human/animal origin o Medicinal substance impacted by change o Ingredient from new supplier with new specification Chart E: Change in sterilization or packaging design that impacts sterilization o New sterilization method o Design change impacts sterilization o Package design impacts sterilization o Extension of expiry without prior NB review of methodology Meanwhile, the following changes are considered acceptable under the transitional provisions: - Change in Authorized representative - Change in manufacturers name, address or legal form (legal entity remains) - New manufacturing sites - Subcontractor, supplier changes - QMS changes (with limits) - Software o Correction of an error with no safety risk o Appearance of the user interface o Enhancements in user interface As always, if there are questions on the guidelines ask your Notified Body (NB). R&Q experts are here to help you navigate the difficult road ahead with ample virtual content and experts on hand so don't hesitate to reach out to your R&Q representative and contact us today.
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Webinars

EU MDR Audits

Preparing, managing and responding to nonconformances.
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News | Webinars

Q&A: Developing an FDA Regulatory Strategy

R&Q's first webinar of 2020 was the first in a two-part series on bringing your medical device to market in the United States. Part one addressed Class I and Class II devices, while part two (TBA in the spring) will cover Class III devices. The questions we received related to January's webinar were phenomenal. In this blog post, we share some answers to those questions and hope you find them helpful. Here's a link where you can register for the on-demand webinar (and download the slides) if you have yet to do so.
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MDD | News | EU MDR

EU MDR 2017/745 Health Check List

Check out R&Q experts' European Union Medical Device Regulation (MDR) 2017/745 Health Check List below to determine the areas to focus your resources in the final few months before the May 26, 2020 MDR Date of Application. If you have questions, concerns, or need any help identifying the areas to prioritize, don't hesitate to reach out to your R&Q representative or contact us today. 1. Be realistic about where you are in the EU MDR transition process and use the resources available to you – we have many listed below! a. Medical device manufacturers and Notified Bodies alike are being stretched thin, so the sooner you can identify what needs to be done the better – time is not on your side. 2. Know your Notified Bodies. a. See a current list at the bottom of this article or conduct your own search here. 3. Do not underestimate the application process – it is very intense! a. You are required to have level 6 CND codes if available, materials and primary function of devices to be identified. Note that CND codes are the product codes used under EU MDR, replacing GMDN as common nomenclature. You can reference the guidance on CND codes here.  b. Expect an average of three rounds of questions for companies with complex product lines. 4. Initiate scheduling for your initial Quality Management System (QMS) audits ASAP. a. Audits are taking at least six months to be scheduled AFTER the application is accepted by the Notified Bodies and a contract is in place. b. Anticipate much more stringent audits on clinical data, consequently you need to focus on closing any clinical evaluation gaps as well as your Post Market Clinical Follow-ups (PMCF). 5. Prioritize completing your Post Market Surveillance (PMS) plans, including PMCF plans, as they must be in place for all devices. a. Although we always recommend full compliance, this is an area that we see many clients struggling due to the depth of new requirements and vague guidelines. Your R&Q representative can help you determine the next steps based on your unique needs. b. Check out our free webinar on PMS Requirements of the EU MDR: Implementation Challenges and Solutions here for additional in-depth information on this topic. 6. Full EU MDR compliance is required if you have Class I devices that are not sterile, measuring or reusable surgical instruments. Full compliance is also required for custom Class III devices. 7. Vigilance reporting needs to follow EU MDR’s 15-day reporting timeline. 8. Registration was due but with the delay in the EUDAMED database to at least 2022, we are following MDD registration. Stay tuned for more guidance for Economic Operators/Manufacturers. a. Check out our blog post on the EUDAMED delay here. 9. No new devices or significant changes in design or intended purpose. a. For example, if you have a certificate for Class IIa devices in a certain family you cannot do a line extension after May 26, 2020 without an MDR certification. 10. The good news is that Class I reusable surgical instruments have been extended to May 26, 2024 for compliance, though they must be on an MDD Declaration of Conformity and meet the "no changes" statement above. a. Be aware of the Implant Card guidance as it now requires a credit card size per ISO/IEC 7810. b. Read our blog post about the EU MDR Class I device delay here. 11. Anticipate that new test results on legacy devices may result in a failure – so do not assume that doing testing for your legacy devices will get supporting evidence of safety/performance. 12. For United Kingdom distributed devices: a. Brexit has happened but not in the “hard Brexit” format that we feared last year. Read our blog post on Brexit: Top Five Do's and Don'ts for Medical Device Manufacturers here. b. It is time to find a new authorized representative now, since transition planning is in process and the current date is December 31, 2020 for the exit. 13. For Switzerland Notified Bodies and manufacturers: a. Contingency plans may be required as Switzerland still has not completed the mutual recognition with the EU. If you are struggling with the above items or having any other issues or concerns with your EU MDR transition, don't delay in contacting your R&Q representative - we are here to help!  Below are the current designated Notified Bodies for EU MDR pulled directly from the European Commission Internal Market, Industry, Entrepreneurship and SMEs Notified bodies Nando tool that can be found here.
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Webinars

PMS Requirements of the EU MDR

Our February 2020 webinar will help you optimize every element of PMS/PMCF as it relates to the EU MDR at your organization.
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MDD | News | EU MDR | Brexit

Brexit: Top Five Do's and Don'ts for Medical Device Manufacturers

After four years, many heated debates, several delays, and a few Prime Ministers later, the United Kingdom (U.K.) is officially leaving the European Union (EU) today, January 31, 2020. Well, sort of. Instead of the “hard Brexit” that had been promised and feared in March, April, and October of 2019, we will instead be entering this phase with a much-welcomed transition timeframe. The current transition allows for most things to remain the same for medical device manufacturers until December 31, 2020. During this transition year, you can continue to utilize U.K. based authorized representatives, European Union Notified Bodies, and sell CE marked devices that meet the EU medical device requirements including both Medical Device Directive (MDD) and Medical Device Regulation (MDR) compliant devices. The most immediate change that occurs as of today is that the 73 U.K. parliamentarians from the 751-seat legislature will exit the EU, meaning the U.K. will no longer be part of the on-going legislative processes. The U.K. will also lose the ability to take the lead on reviews, so if you have a medical device with an integral medicinal substance, the Medicines & Healthcare Products Regulatory Agency (MHRA) will not be allowed to take the lead on that review. They may be able to participate on various committees but will have no voting rights. As we learned from EU MDR, time flies not only when you’re having fun, but also when you’re in a regulation transition period – and trust us when we say that December 31 will be here before you know it. For device manufacturers, here are the top five DO’s and DON’Ts to ensure an on-going ability to distribute your product in the EU: DO transition to an EU authorized representative if you currently have one in the U.K. You will need to register your class I devices that were previously with MHRA with the new Competent Authority based on the location. DON’T underestimate the time it takes to get a new Notified Body. If you have a U.K. Notified Body and have not yet transitioned to another office, the time is now to begin that process. With EU MDR implementation, the lead time to get a new NB is extensive. DO get yourself an EU importer, if applicable. If you are using a U.K. based importer, you will need to arrange for an importer that is part of the EU. DON’T wait to review and modify your contracts. If you need to modify your contracts with your NB and/or economic operators as part of Brexit, now is the time to make sure they are in alignment with the EU MDR requirements which is required by May 26, 2020, even if you are using the MDD soft transition period. DO sign up for e-mail notifications from the U.K. on the transition process. And then actually open and read them when they hit your inbox! Once you have taken care of making sure that you can continue to sell devices in the EU, you also have to consider what is required to continue to sell devices in the U.K. since this is now an independent nation with their own set of rules. As transition and trade deals are still in progress it is hard to define exactly what may be required. Luckily, there is guidance around a hard Brexit which provides some insight into how things may change moving forward: • Potential U.K. responsible person with an address in the U.K.; note that at this time this name does not have to be added to the label. • Separate registrations with MHRA; make sure you have a staff member identified to complete this requirement and watch the dates carefully. • Continue to monitor guidance that are expected to be updated to reflect the transition negotiations as they occur. We know that adding the Brexit transition timeline to your already full plate seems daunting but fear not! Along with your MDR transition, this too can be managed smoothly if you plan carefully and use the resources available to you to meet all new requirements. As always, R&Q experts are just a call or e-mail away if you have any questions or concerns about your company’s ability to stay on top of the ongoing changes in the European Union.
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Events | Minnesota | Medical Alley

POSTPONED: Strategic Solutions for EU MDR Workshop – Minneapolis

March 12, 2020 — Minneapolis, MN
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Events | Boston | massmedic

POSTPONED: Strategic Solutions for EU MDR Workshop – Boston

March 10, 2020 — Boston, MA
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Webinars

Developing an FDA Regulatory Strategy

Our January 2020 webinar is designed to help you create a comprehensive regulatory strategy that enables you to successfully enter the US market.
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News

MDR’s May 2020 Deadline Won’t Change

During a December meeting of the European Union’s Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), European Commissioner for Health and Food Safety, Stella Kyriakides, confirmed that the May 2020 deadline for Medical Device Regulations (MDR) implementation will not change. See the recording of the December 9 public session with comments from representatives across the EU (beginning around 1:37) here. Commissioner Kyriakides brief comments begin around 2:09:10. Below are highlights from the session and few of our takeaways from the impending deadline: The May 26, 2020 Date of Application of the new regulation remains unchanged despite the EUDAMED database delay. 700 experts have applied to serve on the new medical device expert panels. A key pre-requisite for some implantable - & Class III - devices and Article 12 devices (Class IIb devices that channel medicines to or from the body) that may be subject to Clinical Evaluation Consultation Process (CECP). The postponement of the EUDAMED database does not impact the application of the regulations. In other words, the EUDAMED delay should not be used as an excuse for manufacturers not to comply with the MDR. Another three Notified Bodies (NBs) were expected to be designated before the end of 2019. Assuming a maximum of ten NB’s were designated under the MDR by 2019 year-end, this is still well short of the 20 promised by the EU Commission in 2019 and significantly less than 56 NB’s currently designated under the MDD. This implies that NB’s will continue to be overloaded for the foreseeable future and will be less tolerant of Technical Documentation submissions that are deemed to be “non-compliant”, more so, with the capping of rounds of Q&As. Given the inescapable tug-of-war between medical device manufacturer's competing business priorities, we strongly encourage you to act quickly and not to wait until May 2020 to start scrambling. The new MDR requirements take time, resources, and a lot of planning so most organizations need outside support to structure the transition in alignment with their business goals. As always, R&Q will continue to work closely with our clients to ensure that Technical Documentation submissions are Notified Body (NB) compliant. In the meantime, we encourage our clients to reach out to their R&Q account contact to discuss their MDR transition plans.
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News

House Passes Bill to Repeal the Medical Device Tax

The holidays may have just gotten a little happier and a lot brighter for those of us in the medical device industry! Earlier this week, the U.S. House of Representatives passed legislation to repeal the impending and much-criticized Medical Device Tax, a 2.3% excise tax on sales of medical devices in the United States. Originally implemented in 2013 as part of the Affordable Care Act, the tax was slated to come back into effect as of January 1, 2020. In an exciting turn of events, the U.S. Senate is expected to pass the repeal over the next several days, where it would then be sent to the President for signature, sending the tax repeal into effect permanently. If not repealed, the 2.3% Medical Device Tax would have far-reaching and stifling negative effects for the medical device industry. We could expect a significant financial impact on bottom lines, consequently shrinking profit margins, Research and Development (R&D) spending, and operating budgets. It would also have an enormous impact on our patients globally, as the tax takes away dollars from R&D spending, resulting in less innovation and slowed down the delivery of new device advances into the market. According to the Advanced Medical Technology Association (AdvaMed) and a report published recently by the Tax Foundation, there is potential in 2020 for a loss of over 21,000 full-time medical technology jobs if the tax is not repealed. On the other hand, a repeal would likely stimulate the creation of new jobs as it frees up investment funding for product innovation. When R&Q experts consider the immediate impacts of the likely repeal of the Medical Device Tax, we anticipate an opportunity for our clients to have more funding available to support the compulsory transition of their products to meet the new European Union Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), which come into full effect May 2020 and May 2022, respectively. As many in the medical device industry know, the looming MDR and IVDR transitions have us facing enormous hurdles that impact patients as well as our clients’ quality systems, product approvals, product registrations and the addition of clinical and post-market surveillance (PMS) requirements that did not exist before. The new requirements also have significant impacts on product development, clinical affairs, quality and regulatory affairs functions which need to invest time to complete the required transitions. As a full-service medical device, combination product, and IVD consultancy, R&Q has the experience and resources your company needs to tackle the EU MDR & IVDR transitions, as well as drive product innovation with additional funding freed up by the potential permanent repeal of the Medical Device Tax.
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News

BREAKING NEWS: EU MDR Delay Class I Devices

RQM+ clients have one more thing to be thankful for this year as a new Corrigenda to the European Union Medical Device Regulation (MDR) has been issued that extends the due date for Certificates for Class I – reusable surgical instruments – for four years. Check out the newly released document here (English translation begins on page 44). The key message from this document is that if Notified Body involvement is required for a Class I device and the device is on a Declaration of Conformity by May 26, 2020, then it can remain on the market under certain conditions until May 26, 2024. Other Class I devices that have a Notified Body certificate (sterile or measuring) may remain on the market if they have a valid certificate from a Notified Body. In order to take advantage of this extension, the devices must meet the following conditions: 1. Must be on the Declaration of Conformity by May 26, 2020 for the Medical Devices Directive (MDD) 2. Must continue to meet the requirements of the MDD 3. No significant changes in design 4. No significant change in the intended purpose 5. Must follow EU Medical Device Regulation (MDR) post-market surveillance (PMS), vigilance and registration a. Note that starting on May 26, 2020, registration is affected by the European database on medical devices (EUDAMED) delay until May 26, 2022 Keep in mind that the corrigenda has a limited scope and does not extend other deadlines! RQM+ experts will continue to keep an eye on this breaking news and provide updates on our blog as we learn more.
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News

R&Q Cares: Supporting Light of Life Rescue Mission

The R&Q offices are buzzing with excitement as the holidays quickly approach! Many of us are preparing to gather with family and friends this week to celebrate Thanksgiving over a warm meal, football on the TV and great conversation with loved ones. As much as we are a company that loves to celebrate, we equally love to give back to those who really need our help. According to the January 2019 Allegheny County Annual Point-in-Time Homelessness Count, 774 men, women and children were identified as homeless in the Pittsburgh, Pennsylvania area, 73% of whom required emergency shelter at the time of the count. The night this count was taken, the temperature dipped to -5°F. Many of us consider ourselves fortunate that we cannot imagine sleeping outside when the winter air is so cold, but unfortunately this is the life-altering reality for many individuals and families across the country.
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News

Announcing R&Q's new Vice President of Technical Services, Ralph Asencio

Regulatory & Quality Solutions (R&Q) is absolutely delighted to announce Ralph Asencio as Vice President of Technical Services! R&Q has plenty to be thankful for in 2019. It's been an incredible year for a multitude of reasons, one of which has been the addition of key technical experts and leadership with knowledge and skills spanning across all of our service offerings. After more than 20 years with BSI, Dr. Ibim Tariah joined R&Q as Vice President of EU MDR and IVDR Consulting Services. Early in the year, Ron Sills joined R&Q after spending more than seven years as TÜV Rheinland North America's Lead Auditor of Medical. These are just a couple examples of many, and we're proud to add Ralph's name to the list. Ralph's addition helps R&Q expand our technical service offerings, build more strategic partnerships with core clients, expand regulatory intelligence and education offerings to clients, and provide technical guidance and business leadership across the board. R&Q has never been more primed to service our clients. Read on to learn more about Ralph's background (including his experience with global organizations in complex and challenging situations), his new role at R&Q, how he will benefit our clients, and why he's excited to join the team!
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News

EU MDR/IVDR Guidance List Provides Insight on 2019 Expectations

Get ready for an active fourth quarter in the European Medical Device Regulation (MDR) world! We sat down with R&Q's Nancy Morrison, Executive Director of Regulatory and Quality Consulting Services, to get her thoughts on the newly released "Ongoing Guidance development within MDCG Subgroups" document from the European Commission. According to the list published on October 25, there are 18 deliverables still planned for the remainder of 2019 that should provide more information on how the MDR will be implemented. There are, however, still some important topics that appear to be in the early stages such as the definition of a significant change and post-market surveillance (PMS) requirements where a task force still needs to be established. Additionally, one significant missing item that would be especially helpful to R&Q Solutions clients is a template for the creation of Periodic Safety Update Reports (PSUR). As we gain experience in creating EU MDR compliant quality systems and technical documentation these guidance documents will provide a valuable check to ensure our work to date has been meeting the intent of the regulation. It always feels good to get validation for all the hard work that has gone into getting ready for May 2020! Here is what we can expect regarding EU MDR & IVDR guidance in the last two months of 2019: - Template PMCF Plan - Market Surveillance for Class I devices - Clinical evaluation of software - UDI: Integration with QMS, Guidelines on specific product types (working with the US), formats of AICD and HRI parts of UDI Carriers - Classification of IVDs - Nomenclature: Information package on EMDN for a website, list of EMDN codes for implant cards - Multiple clinical investigation guidance documents
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News

Q&A: FDA Updates for Medical Device Manufacturers

From new software and cybersecurity guidance to updates to existing medical software policies, September was a busy month for FDA guidance releases. During our October webinar on FDA Updates for Medical Device Manufacturers, R&Q experts addressed these changes and what impacts our clients should expect. We focused on what is new, notable, and necessary for medical device manufacturers, particularly items that we anticipate will have the biggest impacts on the medical device industry. Here are the areas that our experts think you should be paying attention to right now: the FDA’s two-phase Breakthrough Devices Program, the Medical Device Development Tools (MDDT) originally piloted in 2013, expected changes during the CDRH Reorganization, harmonization and modernization of the Quality System Regulation (QSR) 13485:2016 for medical devices, and the safety and performance-based 510(k) regulatory clearance pathway.
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Events

RAPS Atlanta Chapter: Brexit and EU MDR – Are you Ready?

November 21, 2019 — Alpharetta, GA
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Events

DIA Combination Products Conference – EU MDR Impact to Drug Delivery Devices

October 29-30, 2019 — Bethesda, MD
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Events

FDA Inspections Summit – EU MDR: The Final Push [Panel]

October 24-25, 2019 — Bethesda, MD
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News

"Hope isn't a strategy." Takeaways from RAPS and new industry updates.

September was an incredible month for us at R&Q. Our thought leaders were out and about at DeviceTalks Minnesota, our own 3-hour CER Virtual Workshop (now available on demand), The MedTech Conference (AdvaMed), and the RAPS Regulatory Convergence. Whew! If you participated in any of these events with us, thank you, and we hope you walked away with actionable information and your questions answered. If you're reading this you're well aware our industry is always changing and in order for our subject matter experts to always deliver industry-leading consulting services, we need to stay on top of changes... and that's exactly what we do. We know "hope isn't a strategy," as someone so aptly put it at the RAPS Regulatory Convergence. This post is a short recap of major takeaways from the RAPS Regulatory Convergence and recent industry updates. After reading this post there's a better-than-average chance you may have questions. We encourage you to ask anything here and consult our free  webinars for more information.
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Webinars

Solving the EU MDR Labeling Puzzle

Our December webinar will help you understand and act on requirements.
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Webinars

Strategies for Successful IVDR Implementation

Our November 2019 webinar looked at how to assess products and more.
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Webinars

FDA Updates

Our October 2019 webinar highlighted key areas of change related to the FDA.
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News

Ibim Tariah Joins R&Q

 
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Events

The MedTech Conference (AdvaMed) – CER Panel Discussion

September 23-25, 2019 — Boston, MA
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Events

FDA MedTech Regulatory Forum – EU MDR Panel

August 22, 2019 — Akron, OH
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Events

DeviceTalks Minnesota – Fireside Chat (EU MDR)

September 9-10, 2019 — Minneapolis, MN
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News

Q&A: Integrating CERs and Post-Market Surveillance

While we're in the midst of taking the summer off from webinars (see you in the fall!) and excitedly preparing for our CER Virtual Workshop in September, we did have our most popular and best-reviewed webinar ever in May: Integrating CERs and Post-Market Surveillance. The webinar covered how data inputs and outputs of clinical, regulatory, and post-market documentation interrelate, and must be included in a variety of plans and reports per new requirements detailed in the EU MDR. We introduced a new way to think about categorizing the abundance of information ("data packets"), which based on webinar feedback, resonated with the vast majority of those who viewed the webinar.
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Events

RAPS Regulatory Convergence – EU MDR Panel Discussion

September 21-24, 2019 — Philadelphia, PA
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Events | Webinars

CER Virtual Workshop

Case studies and tips for EU MDR compliant CERS.
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News

Two sides of the regulatory coin

One of the most rewarding aspects of regulatory work is that no two days are the same. There are always new (and constantly evolving) technologies and regulations to provide fresh opportunities to show your skills. If you’ve been tied up trying to get ready for May 26, 2020 and missed the new documents published in the last month, we thought we'd provide you with a short summary of what has been published recently. As we at R&Q well know, the other side of the [rewarding work] coin is that it can be awfully challenging to keep up! We hope you find this helpful and if you'd like to see more posts like this, definitely let us know.
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Webinars

Integrating CERs and Post-Market Surveillance

Data inputs, outputs, and everything in between.
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News

That's a wrap! A recap of our Advanced EU MDR and CER Workshops and what to do if you missed them.

In March R&Q partnered with the Medical Alley Association in Minneapolis and MassMEDIC in Boston to offer industry-leading educational workshops on the EU MDR and CERs. R&Q recruited top industry experts, including representation from notified bodies BSI and GMED North America, along with senior leaders from medical device companies 3M, Abbott, BD, and Boston Scientific. We were delighted the medical device community was interested as evidenced by both venues being filled to capacity! Our sincere thanks to those who attended.
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News

R&Q adds former TÜV Rheinland North America Lead Auditor of Medical to team

Regulatory & Quality Solutions (R&Q) continues to grow aggressively – all while never sacrificing the high quality of service our clients have come to expect (this is a guiding principle and will never change) – and our latest addition to the team is particularly exciting. R&Q is thrilled to formally announce Ron Sills as Senior Principal Specialist and subject matter expert for CERs and the EU MDR. He's been with us since February and has already made significant contributions to the medical device community while at R&Q. In March, Ron supported R&Q's webinar on sufficient clinical evidence (now available on demand) and acted as a panelist for both of R&Q's highly-rated Advanced EU MDR and CER Workshops in Minneapolis and Boston. In his role at R&Q, Ron will provide technical leadership and support to R&Q's clients in all areas concerning EU compliance and remediation. His addition to the team enhances and expands R&Q's capabilities and positions the company to make an even greater impact on our medical device clients... and the industry as a whole.
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Webinars

EU MDR for Combination Products

More companies will require notified body involvement.
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Webinars

Biocompatibility

EU MDR and the changing regulatory landscape.
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Events

Advanced EU MDR and CER Workshop – Minnesota

March 14, 2019 — Minneapolis, MN
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Events

Advanced EU MDR and CER Workshop – Boston

March 19, 2019 — Newton, MA
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Webinars

Sufficient Clinical Evidence

A notified body perspective.
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Webinars

Top 10 EU MDR and CER Questions

Answers to the most popular questions we receive.
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Webinars

Economic Operators

Are they ready for EU MDR? Are you?
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Webinars

Understanding EU MDR and the Roadmap to Compliance

A guide to EU MDR for small companies.
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Webinars

CERs - Tips, Tricks, and Lessons Learned

Clinical background on the new requirements.
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Webinars

Proactive Post-Market Surveillance

The requirements and staff it takes.
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Webinars

EU MDR / CER Portfolio Planning

Know the essential EU MDR portfolio planning requirements.
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Webinars

Preparing your CER for MDR

Gathering clinical evidence.
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Webinars

QMS for EU MDR

Does your quality system meet the additional requirements?
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Webinars

Risk Management Updates

What to do with your process to meet the EU MDR/IVDR requirements.
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Events

Medical Alley Association Annual Dinner

April 24 — Minneapolis, MN
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Events

RAPS Convergence

September 21-24 — Philadelphia, PA
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Events

The MedTech Conference (AdvaMed)

September 23-25 — Boston, MA
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EU MDR | CERs

🏅 Top 10 Questions: EU MDR and CER [Upcoming Webinar]

Are you registered for our next free webinar yet? It's one you won't want to miss and it's next week!
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News

What does Brexit mean to your medical device company?

Hope for the best, but prepare for the worst.
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EU MDR | CERs | California | DeviceTalks West

Our Advanced EU MDR and CER Workshop is coming to California in December at DeviceTalks West

  Note: Presenters/Panelists listed below subject to change. R&Q is bringing our Advanced EU MDR and CER Workshop to DeviceTalks West! Join us Dec.12 for an extensive, detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. These experts have seen what works and what doesn't, and will be sharing tips, tricks, and lessons learned. What's more, if you'd only like to attend the workshop and not the entire conference, we've made that possible. Here are the registration codes: RQFULL - 50% full conference pass RQWORKSHOP - $75 for workshop only (also includes networking opportunities) At a small company and think this doesn't apply yet? This may not be on your radar, but it should be. You'll learn from the successes and failures of larger companies who are several months into the transition, and acquire the knowledge to nimbly navigate the transition efficiently. If your organization has many device changes planned, it’s crucial to get started in order to complete the transition by May 2020. Read on for a closer look at the workshop and an exclusive registration discount code for DeviceTalks Boston.
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New webinars, major events... hello, fall!

First thing's first: our free webinars are back. Over the next three months – beginning September 25 – we'll be covering combination products, EU MDR, and economic operators. Slides, recordings, and Q&A will be made available to everyone who registers. We've made it easy for you to sign up once and get on the list for all three webinars below. Why sign up? Because our industry-leading experts are sharing lessons learned from experiences they've lived through. We present the most important information and compile critical takeaways we believe you can implement right away.    
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R&Q | Careers

R&Q Q&A: Employee Spotlight and Career Opportunities

This is our R&Q Q&A series. Every few months we ask R&Q employees how they make their impact at R&Q... and the impact R&Q has had on them. From improving people's lives to R&Q's rewarding culture, we hope their answers shed light on how our company influences the medical device industry and why our employees claim time and time again working at R&Q is a highly fulfilling experience. View all R&Q openings on our Careers page.
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EU MDR | CERs | DeviceTalks Boston

Not your average EU MDR and CER workshop

Note: Presenters/Panelists listed below subject to change. DeviceTalks Boston is Oct. 8-10 this year and as part of it, R&Q is helping to organize an Advanced EU MDR and CER Workshop. It's an extensive, detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. They've seen what works... and what doesn't, and will be sharing tips, tricks, and lessons learned. At a small company and think this doesn't apply yet? This may not be on your radar, but it should be. You'll learn from the successes and failures of larger companies who are several months into the transition, and acquire the knowledge to nimbly navigate the transition efficiently. If your organization has many device changes planned, it’s crucial to get started in order to complete the transition by May 2020. Read on for a closer look at the workshop and an exclusive registration discount code for DeviceTalks Boston.
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Minnesota | DeviceTalks | DeviceTalks Minnesota

Taking it up a notch at DeviceTalks Minnesota

DeviceTalks Minnesota is right around the corner and we couldn't possibly be more excited - really. June 4-5 is only a little over three weeks away! We've witnessed the growth of this event first-hand over the past few years and this year we're confident will be the best yet, especially considering the new partnership with the Medical Alley Association (MAA). R&Q sees this as the premier medtech event in Minnesota in 2018, which is why we've decided to be a Platinum Sponsor this year. Beyond that and most importantly, we're helping to craft the educational content of the Regulatory 2.0 track, presented by MAA. 
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regulatory | EU MDR | CERs

🔑 Unlock the Secrets to CERs in our May Webinar

Unlock the secrets to complying with the increased requirements for CERs in May's free R&Q webinar:   CERs – Tips, Tricks, and Lessons Learned     The session will be on Tuesday, May 22 from 1:00pm - 2:00pm EST. The presentation slides, webinar recording, and Q&A will be made available to registrants - whether you can attend the live presentation or not.   Webinar details You have heard about the increased requirements for clinical evaluation with MEDDEV 2.7/1 Rev 4 and the MDR. You may be working on new templates and updating your CERs.   And now come the questions... What do these requirements really mean? Why are we doing this? How are we going to get this all done?  
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EU MDR | Technical Documentation

💼 EU MDR – Proactive Post-Market Surveillance [Upcoming Webinar]

It's time for our next free R&Q Intelligence Series webinar. The session – EU MDR – Proactive Post-Market Surveillance: The requirements and staff it will take to do it. – will be held Tuesday, April 24ᵗʰ from 1:00pm - 2:00pm EST. If you can't view the webinar live, we encourage you to register anyway, as the presentation slides, webinar recording, and Q&A will be shared with all registrants. Click below to sign up and read on for more details about the webinar. We hope you can join us!  
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R&Q | Careers

R&Q Q&A: Employee Spotlight and Career Opportunities

Welcome back to our R&Q Q&A series. Every few months we ask R&Q employees how they make their impact at R&Q... and the impact R&Q has had on them. From improving people's lives to R&Q's rewarding culture, we hope their answers shed light on how R&Q influences the medical device industry and why our employees claim time and time again working at R&Q is a highly fulfilling experience. View all R&Q openings on our Careers page.
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Webinar Q&A: Preparing your CER for MDR

Note: R&Q's first Intelligence Series webinar of 2018 will be held on January 23rd – QMS for EU MDR: Does your quality system meet the additional requirements? Sign up here! -- Back in November and as part of the R&Q Intelligence Series, we held the webinar, Preparing your CER for MDR: Gathering Clinical Evidence. The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. The time to plan and act on these changes is most certainly now. At the conclusion of the November webinar we answered many questions (the most of any webinar - so thank you!), and some of those questions and answers are below. To read more about the webinar, read all questions and answers, and gain access to the slides and recording, check out the on-demand webinar.
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Medical Devices | News | R&Q | EU MDR | R&Q Hires

Welcome, Jacob Foster: Regulatory and Quality Solutions' New Senior Principal Engineer

Jacob Foster brings 20+ years of medical device and pharmaceutical regulatory, quality, and project management experience to R&Q. He also brings an engaging personality, eager to do more for clients. Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q) exists to improve people’s lives and bring more safe and effective medical devices to market for medical device and combination product companies. Our results derive from a cohesive, hard-working, entrepreneurial, and supportive culture – a culture in which Jacob Foster effortlessly fits in. R&Q is truly ecstatic to announce that Jacob Foster has been named Senior Principal Engineer. An industry veteran of the global pharmaceutical and medical device industries, Foster brings extensive management, project leadership, and hands-on quality systems development experience to R&Q’s rapidly expanding operations team. His years of experience in the ever-changing regulatory environment  - including the upcoming and all-important EU MDR - strengthens R&Q's ability to expertly and efficiently serve clients. Foster has lived through uncertain times in the industry and despite the complexity of changes, has a track record of successfully navigating and deciphering them. “I met the team at R&Q about three years ago, and became “fast friends” with each and every team member I was introduced to," said Foster. "So when the opportunity arose to join R&Q, it was one of the easiest decisions I have ever had to make. The culture of R&Q and the earnest sincerity to contribute to patient safety and client success is tangible. Who would not want to be a part of that?”
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CER | Clinical Evaluation Report | EU MDR | Clinical Evidence

Preparing your CER for MDR [Upcoming Webinar]

The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market for a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. R&Q's next Intelligence Series webinar, Preparing your CER for MDR: Gathering Clinical Evidence, will be held on Tuesday, Novemer 28th from 1:00pm - 2:00pm EST.  The presentation slides, webinar recording, and Q&A will be made available to registrants. Register in seconds at the link below, and read on for full webinar details. We hope you'll join us!
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QMS | News | iso 13485 | AAMI | Resources

ISO 13485:2016 Companion Handbook Now Available

ISO has published a companion handbook to ISO 13485:2016, Medical devices-Quality management systems - Requirements for regulatory purposes. From AAMI: It provides users with practical guidance and accurate interpretation of the requirements specified in the standard. It offers device manufacturers step-by-step guidance applicable to the all stages of a medical device's life cycle from gathering customer requirements to design and through to post-market surveillance of devices. This go-to resource is ideal for regulatory, compliance, quality management professionals who are committed to implementing and maintaining a quality management system that is effective and meets applicable regulatory requirements.
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Webinar Q&A: EU MDR / CER Portfolio Planning

In September and as part of the R&Q Intelligence Series, we conducted the webinar, EU MDR / CER Portfolio Planning: Know the essential EU MDR portfolio planning requirements. Portfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules. At the conclusion of the webinar we answered several questions, and a sampling of those questions and answers is below. To read more about the webinar, read all questions and answers from the session, and gain access to the slides and recording, check out the on-demand webinar.
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Webinar Q&A: Risk-Based Approach to ISO 13485:2016

Last month and as part of the R&Q Intelligence Series we conducted the webinar, Risk-Based Approach to ISO 13485:2016: Risk considerations and implementation. Risk considerations and implementation of a risk-based approach in your QMS processes is one of the most significant changes to the current version of ISO 13485. Medical device organizations must define how they manage risk in their processes and how the risk of one process affects other risk aspects of the QMS. At the end of the webinar we answered several questions, and a sampling of those questions and answers is below. To read more about the webinar, read all questions and answers from the session, and gain access to the slides and recording, check out the on-demand webinar.
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CER | EU MDR

EU MDR / CER Portfolio Planning: The Essential Requirements [Free Webinar]

What?  Please join us for September's free R&Q Intelligence Series webinar: EU MDR / CER Portfolio Planning: Know the essential EU MDR portfolio planning requirements. The session will take place Tuesday, September 26 from 1:00pm - 2:00pm EST.   Portfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules. The time to plan is now.
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MEDDEV 2.7/1 & CERs: Questions and Answers

Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7/1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision. Furthermore and once the regulation comes into force, the European Medical Devices Regulation (MDR) will impact CERs as well. It is important to be proactive to ensure CERs will meet your notified body expectations. You must review your clinical strategy carefully. R&Q recently presented the webinar, MEDDEV 2.7/1 & CERs: Know the changes and what to do. Towards the end of the session we answered several questions, a sample of which are below. To see all questions and answers from the session - along with the slides and recording - check out the on-demand webinar.
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Cybersecurity for Medical Devices: Questions and Answers

As the number of network connected medical devices increases, opportunities for improved patient care also increase. As a consequence, the vulnerability to cyber-attacks becomes a greater threat. Medical device cybersecurity threats can be dangerous for providers, networks, and device manufacturers. They can put patient safety at risk and/or create a breach of data. The FDA encourages manufacturers to consider potential cybersecurity risks and vulnerabilities “throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device.” R&Q recently presented the webinar, Cybersecurity: Regulatory and quality ramifications. During the session we answered several of your questions, a sample of which are below. To see all of the questions and answers from the session, along with the slides and recording, check out the on-demand webinar.
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FDA

MDUFA IV: More Than Just User Fees - FDA Reauthorization Act (FDARA) Passes Senate

Pending the expected signature of President Trump, MDUFA IV will be implemented (along with PDUFA VI and GDUFA II). Passage, including the associated rise in user fees for device manufacturers over the term of the act (FY18-22), was largely expected. Legislative politics involve give-and-take, of course, and increased user fees are reasonably expected to result in systemic improvements in regulation, via industry favored initiatives. FDA has described their “give” portion of the give-and-take process in the document MDUFA Performance Goals and Procedures, Fiscal Years 2018 Through 2022. Unsurprisingly, focus remains on Total Time to Decision metrics for premarket submissions. The linked MDUFA Performance Goals document describes some of the approval or clearance process mechanisms by which improvements in Total Time to Decision might be achieved, as well as various cooperative review mechanisms planned. The Pre-Sub program will be continued, with specific requirements on response timing and meeting date options, and required publication of an updated version of the Request for Feedback on Pre-Market Submissions guidance document. Another provision of the bill requires annual reporting on the previous year’s inspection activities for device and drug facilities, including timing information. Those who have been subjected to lengthy or highly intermittent inspections, or delays in comment on response adequacy, are likely to welcome this additional scrutiny of inspection timelines.
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remediation | FDA | Case Studies | Clinical Evaluation Report | MEDEV 2.7/1

Clarifying the Clinical Evaluation Requirements: A Case Study

About R&Q's Case Studies: We hope this Clinical Evaluation Report case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies and other resources are available. Questions on this particular subject? Contact us. Challenge Design changes and MEDDEV 2.7/1 rev 4 compliance. The client was implementing multiple design changes on a Class III implantable heart transplant device that required a submission to the Notified Body. As part of this submission, the Clinical Evaluation format needed to be updated to provide clarity and comply with MEDDEV 2.7/1 rev 4. The Notified Body provided feedback on the prior clinical evaluation reports and the client needed assistance in interpreting and addressing the feedback. The primary roadblocks / challenges were interpreting the information provided by the client, identifying and requesting any missing or insufficient documentation, and ensuring the information was comprehensive and understandable to the Notified Body once included in the Clinical Evaluation Report.
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Regulatory Affairs | EU MDR

EU MDR: Your Questions, Our Answers

On May 5, 2017 the EU MDR (Medical Device Regulation) was published in the EU Official Journal. This date starts the three-year mandatory transition period where the MDR will replace the MDD (Medical Device Directive). The expanded scope of the MDR combined with the time frames for compliance is compelling medical device companies to focus significant attention on transition strategies and will require substantial hands-on work. R&Q recently presented the webinar, EU MDR: Assessing the Impact and Next Steps. During the session we answered several of your questions, a sample of which are below. To see all of the questions and answers from the session, along with the slides and recording, check out the on-demand webinar.
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R&Q

Regulatory and Quality Solutions Names Julie Maes Director of Territory Operations – Northern Lakes Region

Maes brings 25+ years of medical device regulatory, quality, and project management experience to R&Q. Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q), a provider of industry-leading regulatory and quality engineering services to medical device and combination product companies, announced that Julie Maes has been named Director of Territory Operations for Minnesota. An industry veteran of the global healthcare and medical device industry, Maes brings extensive management and hands-on quality systems development experience to R&Q’s expanding Minnesota area operations. In her role at R&Q, Maes will manage designated resources to guarantee the highest quality consulting and complete customer satisfaction in the region. She will also contribute to R&Q’s Center of Excellence as a subject matter expert, providing industry education on the most critical and timely regulatory and quality challenges facing our market.
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cybersecurity | FDA

The Lowdown on Cybersecurity for Medical Devices

Every one of us has probably either been affected by or knows someone who has been affected by a cybersecurity vulnerability. Some attacks happen for the thrill, some to expose weaknesses between competitors, some for malicious intent, and some for money. We hear of these issues in our daily life - from computer viruses to financial incidents. These types of threats have certainly surfaced in the medical device industry and we need to make sure we are positioned to address these early in the product development process and the post-market space. The ultimate goals are to make sure that a weakness in cybersecurity practices does not affect the functionality of a medical device in a harmful way, and to make sure sensitive patient data is protected as defined by region-specific regulations.
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cybersecurity | Regulatory Intel | webinar | Quality Intel

[Free R&Q Webinar] Cybersecurity for Medical Devices: The regulatory and quality ramifications.

What?  Please join us for a free R&Q Intelligence Series webinar: Cybersecurity for Medical Devices: The regulatory and quality ramifications. The session will be held on Tuesday, July 25 from 1:00pm - 2:00pm EST.
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IVDR | EU MDR

RESOURCE: The MDR and IVDR Have Been Published! See Our Table of Key Dates

Publication in the Official Journal of the European Journal on May 5, 2017 means the regulations will enter into force on May 26, 2017, twenty days after publication. We will have a three-year transition period for the MDR and a five-year transition period for the IVDR. Products can be issued a certificate under the MDD with a full five-year expiry for the first two years of the transition period but should comply with all other aspects of the MDR in May, 2020. Since most IVD products are currently on the market as a self-certified they will require certificates by the end of the five-year transition period where most products now require Notified Body involvement.  
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webinar | CER | MEDDEV

MEDDEV 2.7/1 & CERs: Know the Changes and What to Do [Webinar]

Part of your month, [almost*] every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: July 25th, where we'll discuss cybersecurity (*there will be no R&Q Intelligence Series webinar in June).
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EU MDR

EU MDR and Clinical Evidence: What You Need to Know

THE SKINNY: The Council of the European Union adopted the proposed new European Medical Device Regulation (EU MDR) in March 2017 and passed by Parliament in April 2017. It is expected to be published in the Official Journal of the European Union in the upcoming weeks, making the application date mid-2020. The EU MDR will replace the Medical Device Directive (Council Directive 93/42/EEC) and the Active Implantable Medical Device Directive (Council Directive 90/385/EEC). Among the vast changes occurring with this transition from directive to regulation are the new requirements surrounding clinical evidence. If you found the clinical portion of your technical documentation to be challenging in the past, you need to prepare for some additional hurdles.   ~ Note: This post is just a taste of the detail we'll explore during our R&Q Intelligence Series webinar on EU MDR April 25th at 1:00pm EST. All registrants will have access to the slides and recording from the session.  
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webinar | EU | Europe | European Union | EU MDR

EU MDR: Assessing the Impact and Next Steps [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: May 23rd, where discuss MEDDEV 2.7.1 & CERs.
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FDA | MDSAP

MDSAP: A Better Inspection Option for Device Manufacturers?

Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal at R&Q. Jake has more than 20 years of experience working for the FDA. Please join us for a free one-hour webinar on MDSAP, March 28th. Medical device firms, are you looking forward to your next FDA inspection? I have conducted around 400 of them, and I am still trying to think of an instance when the firm was happy to see me. I never took it personally. FDA inspections can be stressful, not to mention they are very expensive and time consuming to support. Furthermore, FDA inspections are often followed by an unpleasant period of uncertainty regarding outcomes and adequacy of responses.
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webinar | audits | FDA | MDSAP

MDSAP: What is it? Is it for me? How will I get it done? [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: April 25th, where we'll discuss EU MDR.
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FDA | regulatory | regulatory strategy | draft guidance

Review Controls Applied to Outgoing Data Streams (Because the FDA Might Be)

Medical device manufacturers need to carefully manage several important outward streams of information regarding their products. The regulatory community is generally most familiar with the data stream that relates to obtaining clearance to market devices, which involves communications directly with the FDA. The FDA data stream is customarily well integrated with a firm’s internal regulatory functions of review and approval. However, there are other data streams that are critical to the commercial success of device manufacturers.
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News | medical device news | Jake O'Donnell

NEWS: Bill Introduced to Improve FDA's Medical Device Inspection Process

Senator Johnny Isakson [R-GA] Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal at R&Q. Jake has more than 20 years of experience working for the FDA. We hope his commentary brings a useful perspective to the new bill. Anytime there is an administration change in the federal government, thoughts turn to potential changes in the regulatory environment. With a Republican chief executive and majorities in the 115th Congress, this year is no exception. On February 15th, Senator Johnny Isakson [R-GA] introduced S.404: a bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.
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QMS | webinar | Risk | iso 13485

A Risk-Based Approach to Your QMS Implementation - ISO 13485:2016 and ISO 9001:2015 [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: March 28th, where we'll discuss the Medical Device Single Audit Program (MDSAP).
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remediation | FDA | 510(k) review | 510(k) | Case Studies | Acquisitions

Acquisition Regulatory Assessments: A Case Study

About R&Q's Case Studies: We hope this Acquisition Regulatory Assessments case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies and other resources are available. Questions on this particular subject? Contact us. Challenge Investigating acquired products and associated FDA clearances. A client took ownership of numerous products they had obtained through an acquisition. Remediation of the regulatory documents was needed, which included a review and evaluation of the 510(k) products to establish whether or not the current marketed products aligned with the existing FDA clearances. R&Q conducted a 510(k) inventory, which required a significant amount of investigation work to compile a list of all applicable products and associated 510(k) clearances, as well as non-filing justification (NFJ) with regard to design changes.
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R&Q | Minnesota | Careers

R&Q Q&A: Minnesota Spotlight

Welcome to the third post in our R&Q Q&A series. Every few months we ask R&Q employees from a different region questions about how they make their impact at R&Q... and the impact R&Q has had on them. From improving people's lives to R&Q's corporate culture, we hope their answers shed light on how R&Q influences the medical device industry and why our employees claim time and time again that working at R&Q is a highly rewarding experience. See current Minnesota openings at the end of this post, and view all R&Q openings on our Careers page.
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R&Q | Engineered By Women

Regulatory and Quality Solutions (R&Q) Certified By the Women’s Business Enterprise National Council

R&Q, provider of industry-leading regulatory and quality consulting and engineering services to medical device companies, is proud to announce national certification as a Women’s Business Enterprise by the Women's Business Enterprise Council-PA-DE-sNJ, a regional certifying partner of the Women’s Business Enterprise National Council (WBENC). The designation signals a competitive advantage for R&Q’s FDA-experienced team of more than 80 RA/QA experts as medical device and pharmaceutical companies often look to vary their supplier base with more diversity and/or minority-owned businesses. The honor is especially meaningful to Cofounder and President, Maria Fagan, and has been a long time in the making...
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cancer | medtech | meddevice | wearables

A Cool New Way to Prevent Cancer Hair Loss — Literally

♫ Baby, It's Cold Outside, especially in Texas, where a clinical trial showed a new cooling cap system can prevent hair loss in cancer patients. The ongoing trial involved 95 women with early stage breast cancer. After four cyles of chemotherapy, 48 of the patients—or 51 percent—retained their hair. Meanwhile, 47 control patients had no hair after four rounds of chemotherapy. The results were so striking that researchers decided to stop the study early and report their findings at the San Antonio Breast Cancer Symposium last week. 
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Pittsburgh | R&Q | Philadelphia

Headway in PA: Announcing Dedicated Operations Directors in Pittsburgh and Philadelphia

In 2016 R&Q expanded its activities and the amount of clients served in the northeast (specifically, the greater Boston region), formally launched R&Q in Minnesota, and continued to service new and existing clients throughout the state of Ohio. In 2017 we plan to strengthen our capabilities in those areas and others by hiring some of the most qualified regulatory and quality professionals in the industry (who also are a cultural fit for R&Q). But with that said, we'll never, ever lose sight of where we started and ultimately call home: Pennsylvania. R&Q has hired - or rather, promoted from within - dedicated operations directors in Pittsburgh and Philadelphia. Each director is tasked with ensuring R&Q is represented in the territory through: Serving medical device clients and helping them thrive Engaging in regional marketing/networking initiatives Ensuring the growth of ongoing sales Read on to learn more about R&Q's Jon Gimbel and Matt Burger.
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Case Studies | process validation

Process Validation Case Study: Know What You Know... and What You Don't

About R&Q case studies: We hope this process validation case study helps you understand how we serve our medical device clients in this area. If you have specific process validation questions please contact us and we'll be happy to help. Looking to solve a different problem? Here are all of our available case studies. Subscribing to our blog is the best way to know when future case studies are available. Challenge Transfer troubles. A company executed site transfer and design transfer together for a newly developed product without an in-depth understanding of the product and its manufacturing process. The lack of detailed product specifications, in-depth process design, and full process validation left the program team searching for a baseline to deem the product as acceptable once the design and equipment was transferred to its new location. The result? The program experienced setbacks in implementation and found itself handling a larger-than-ideal number of nonconforming lots.
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QMS | iso 13485

Vital To-Do for 2017: Prepare for ISO 13485:2016

“Procrastination is the bad habit of putting of until the day after tomorrow what should have been done the day before yesterday.” - Napolean Hill It's really never too early, especially when it comes to renewing the certifications you need to keep your product on the market. In fact, the time is now to start your transition to ISO 13485:2016. Certification bodies will have difficulty having enough auditors and long wait times are expected. Don’t get caught in that last minute rush to renew certifications. R&Q’s QMS expert, Mark Swanson, was a member of the ISO working group that revised ISO 13485, so R&Q can bring you detailed information on the intent behind the requirements. R&Q on the whole will ensure you can fully prepare for your certification audit with minimal issues, keeping your product on markets worldwide.
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iso 10993 | iuvo BioScience

Slides and Webinar Recording: Chemical Characterization Requirements

Missed our webinar with iuvo BioScience - Chemical Characterization Requirements: ISO 10993-18 and Extractables & Leachables Requirements? Good news: you can now download the slides and view the recording.
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Ohio | BioOhio | Regulatory 101 | startups

Next Up: FDA Regulatory 101 with Combination Products Spotlight at Heal Ohio Conference

This is the last FDA Regulatory 101 installment of the year for our partnership with BioOhio. After events in Cincinnati and Columbus, the October 27th event will be held during the 2016 Heal Ohio Conference at the University of Akron. Former FDA Consumer Safety Officer Jake O'Donnell (25+ years of FDA experience) will be presenting and answering questions, in addition to other industry experts. What's more, those who register for the 101 event are eligible for a discount to the conference. Keep reading to see the agenda and register to attend.
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submissions | PMA | 510(k) | advamed

Master 510(k), IDE, and PMA Submissions at AdvaMed's Workshops

Within driving distance to D.C.? There's still time to enjoy a few days there next week and simultaneously hone your submissions skills. The FDA, R&Q, and other talented industry experts courtesy of AdvaMed are offering three workshops dedicated to teaching you the guidelines for successful 510(k), IDE, and PMA submissions. Engage in interactive workshops and hear from industry professionals - such as R&Q's Director of Regulatory of Affairs Nancy Morrison and Senior Principal Advisor Marilyn Waxberg. The AdvaMed events are some of the best in the business, and R&Q is proud to be included as part of the faculty. Read on for details! 
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massmedic | CAPA

CAPA on CAPA: Webinar Slides and Recording

Missed our CAPA on CAPA webinar with MassMEDIC? Now you can download the slides and view the recording.
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FDA | CDER | CDRH | Conferences

The REdI Fall 2016 Conference: Slides and Recordings

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. The FDA holds these conferences only twice a year, which doesn't give medical device companies too much wiggle room when it comes to clearing their busy shedules to attend. So if you missed the conference, R&Q will fill you in!
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iuvo BioScience | ISO 10993-18

Free Webinar: Chemical Characterization Requirements: ISO 10993-18 and Extractables & Leachables Requirements

What? This joint webinar presented by Regulatory and Quality Solutions (R&Q) and iuvo BioScience is focused on the requirements for chemical characterization in the healthcare industry. Specifically, it will discuss the standards required for ISO 10993-18 chemical characterization for medical devices and compare the ISO requirements with the pharmaceutical industry requirements and best practices for extractables and leachables testing. The goals for this webinar are to explain the standards for both industries, discuss the testing methodologies required, and provide some case study experience from an E&L perspective. You can register here.
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R&Q | Careers

R&Q Q&A: Northeast Employee Spotlight and Openings

Welcome to the second post in our R&Q Q&A series. Every few months we ask R&Q employees from a different region questions about how they make their impact at R&Q... and the impact R&Q has had on them. From improving people's lives to R&Q's corporate culture, we hope their answers shed light on how R&Q influences the medical device industry and why our employees claim time and time again, that working at R&Q is a highly rewarding experience. In June, we talked to two key members of the Boston team - view their responses here. See current northeastern openings at the end of this post, and view all R&Q openings on our Careers page.
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Medical Devices | quality systems | News | iso 13485 | R&Q | Minnesota

Minnesota Momentum: R&Q Hires Member of ISO Technical Committee 210, Mark Swanson

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory. Welcome, Mark! Mark's addition firmly establishes R&Q in the Twin Cities and prepares R&Q to handle growth in the region. The hiring also builds upon R&Q's existing technical leadership, increasing company-wide capability. Mark will certainly be seen and heard across Minnesota on behalf of R&Q, starting today at MD&M Minneapolis! Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE). Read on as we ask Mark three questions about his work on the ISO Technical Committee and shed light on his background/experience.
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warning letter | remediation | FDA | supplier quality | Case Studies

Revamping Supplier Quality: A Case Study

About R&Q's Case Studies: We hope this Supplier Quality Remediation case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies are available. Questions on supplier quality remediation? Contact us. Challenge The FDA found that not following your procedure is a problem. A multibillion dollar client had a supplier quality process that was not being executed, and was not aligned to regulations (21 CFR 820.50). Suppliers were not being audited at the prescribed regularity, some suppliers rated as low risk were making high risk parts, and others supplied product that did not meet current specifications. The results of an FDA inspection resulted in a Warning Letter that ultimately required third party audit certification. The organization had to react by proposing a plan to halt distribution of two product lines in order to focus on a permanent and comprehensive systemic solution.
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remediation | FDA | Case Studies | CAPA | CAPA remediation

When CAPA Needs a Corrective Action: A CAPA Remediation Case Study

About R&Q's Case Studies: We hope this case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies are available. Questions? Contact us. Challenge The FDA found problems you didn't think were there. A multibillion dollar client has been marketing product for years with insufficient attention to corrective actions. An analysis of the CAPA records showed 62 open CAPA’s at inception, with an average age of 1.3 years each. The client believed that their process was adequate and therefore did not apply the necessary resources to find a solution. Additional lack of response to FDA Warning Letters resulted in a consent decree, which included the need to improve the CAPA process.
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usability | Pittsburgh Technology Council | human factors

Medical Device Development: Avoiding Pitfalls in Human Factors / Usability and Design

This article was originally published in Summer of 2016's Made in PA issue, a publication of the Pittsburgh Technology Council. The competitive landscape of medical devices combined with the advantages of being first to market often tempt manufacturers to move through the product development process at a rapid pace. Deficiencies in the production and process controls subsystem of the Quality System Regulation (QSR) accounted for 32% of the 483 observations cited in 2015.¹ Inadequate Design Controls accounted for 15% of the 483 observations in the same time period. It's no surprise that Warning Letters related to Quality System problems in 2015 often focused on those two areas, along with the Corrective and Preventative Actions (CAPA) subsystem.  A robust Quality System is certainly the first line of defense that device manufacturers must have in place not only to be compliant with Food and Drug Administration (FDA) regulations, but also to avoid costly mistakes during product development and beyond. Here are a couple of items to consider.
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Regulatory 101 | PA Bio | Philadelphia | startups

Med Device and Med Tech Startups: Master Regulatory Basics and More! September 22 in Philly

We all gotta start somewhere... and Pennsylvania Bio and Quorum have helped us put together an invaluable event to help your early-stage medical device company hit the ground running. Seasoned experts, such as R&Q's President Maria Fagan and Buchanan Ingersoll & Rooney's Will Garvin will be presenting content and answering any and all of your questions and curiosities (you have the chance to submit them in advance during registration). The Regulatory 101 for Medical Device And Med Tech session is September 22 in Philadelphia and we encourage you to register early!
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QMS | audits | audit | Quality System

5 Reasons Not to Fear a Supplier Audit

The following post is written by R&Q Senior Engineer, Michelle Mahoney. One of the toughest things to experience when walking in to audit a company is the tension, anxiety, and fear emanating from those in the room. Taking a look around the room, I notice heads are turned away, eyes are up counting the ceiling tiles, and no one will even make eye contact with me. I already felt like an outsider walking into this company alone, but now I feel it even more so. I realize it's up to me to break the ice and try to settle the nerves of everyone in the room. "So how 'bout them Red Sox?" Ok, there's a smile. A chuckle. Some eye contact. Success! ...alright, so that only works when I’m in New England... but you get the idea.  It's really up to me, as the auditor, to set the mood of the audit within the first few minutes of walking through the door. As much as I hope that the company will be comfortable and relaxed with hosting an audit, there are almost always nerves and anxiety running wild. One potential reason? The auditees feel the pressure to have a successful audit because if they don't, top management might have a word or two about it. But what the auditees need to realize is that there is nothing to be scared of, and here's why.
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News | FDA | 510(k) submission | regulatory news | compliance | 510(k)

What You Should Do About the Two New FDA Draft Guidance Documents

It has been a long journey for the FDA to get the new draft guidances published on when to submit a 510(k) for a change to an existing device, and another specific to software changes. But on August 8th, 2016 it finally happened! For those of you who remember the FDA's attempt at updating the 1997 Memorandum in 2011, that draft guidance was met with general industry pushback, congressional input, an FDA report to congress, and now a new draft guidance.
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Quality System | regulatory | massmedic

Free Webinar: CAPA on CAPA, Presented by MassMEDIC and R&Q - Register Now!

CAPA is often overlooked as an integral component of a quality system. More often than not, the FDA can trace deficiencies in a system directly back to the CAPA system. However, an effective quality system needs more than just a rework of the outcome of the ineffective CAPA system. It needs a rework of the system itself. 
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start ups | medical device | startups

R&Q's Christine Santagate Featured in Medical Design & Outsourcing

Staying at the forefront of the medical device industry takes work - a lot of it, in fact. Communication with R&Q's peers in the industry is in large part how our employees do it, and a big part of that is addressing hot topics in the industry. R&Q's own Client Solutions Advisor Christine Santagate was featured in MassDevice's May 2016 issue of Medical Design and Outsourcing in an article titled, "Everything You Ever Wanted to Know about Starting a Medical Device Company." The publication serves as a fantastic how-to guide for startup companies. Here's what she had to say.
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FDA | Ohio | BioOhio | Regulatory 101 | Regulatory 201

July is a BIG month for R&Q in Columbus, OH

■ ■ ■ Are you an Ohio Bioscience Expo & Showcase attendee here to register for the FDA Regulatory 101 Series? ■ ■ ■   The Ohio Bioscience Expo & Showcase and next FDA Regulatory 101 Series event are on July 27th and 28th, respectively. If you're outside of Columbus but in Ohio, you're likely close, and there's no better time for a road trip than the middle of summer! In fact, here are drive times to Columbus, OH from some nearby cities: Cleveland: 2 hours 9 mins Cincinnati: 1 hr 41 mins Toledo: 2 hr 29 mins Akron: 1 hour 55 mins Dayton: 1 hour 5 mins Canton: 2 hours 2 mins If you can drive to Columbus, OH in a single day, the only thing between you and R&Q on July 27th and 28th is a little open road. Below are all the details you need to know and be sure to save your seat for the FDA Regulatory 101 Series event!
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biosense | News | wearable tech | sensors | innovations | wearables

Wearables are Exploding (Not Literally!) and Transforming the Medical Device Industry

Image via Verily Smart wearables are turning into a largely profitable industry. From glucose monitoring, to sleep technology, to fitness apps, the number of wearable medical devices on the market are continuing to grow and in turn, help the lives of people - with or without ailments. Many of these devices are meant to ease daily life and prevent invasive and potentially harmful procedures for patients all over the world. This technology also encourages wearers to be actively involved in bettering their own health behaviors. These innovative devices typically fall into the three categories below.
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iso 13485

10 Tips for Adopting the Updated ISO 13485:2016 Standards: Webinar Slides and Recording

Missed our latest webinar on this year's ISO 13485 changes? Now you can download the slides and recording. R&Q's Director of Regulatory Affairs Nancy Morrison and Client Solutions Advisor Christine Santagate walked through 10 tips for adopting the latest changes. From conducting a gap assessment and creating a quality plan to modifying procedures/processes and auditing, they communicated industry best practices to help those in the industry confidently take the next steps in their process.
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usability | FDA | human factors | pma supplement | PMA | Case Studies | IEC 62366

FDA Approved: A Human Factors and Usability Case Study

About R&Q's Case Studies: We hope you enjoy our latest case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available. FDA Approved: Creating and Implementing a Compliant Usability Engineering Process Challenge PMA supplement for usability updates not approved. A medical device manufacturer made an update to the design of their Class III device to improve usability and promote proper care and maintenance, and they submitted a PMA supplement to the FDA for the changes. The PMA supplement included a human factors test report from a usability study intended to demonstrate the effectiveness of the changes. The company received a letter from the FDA expressing concern with the level of evidence provided by their human factors testing. The FDA noted that the recent usability study had focused on ease of handling rather than comprehensive safe and effective use, engaged company employees as study participants rather than unaffiliated representative users, and failed to demonstrate that risks related to the most critical aspects of device use had been appropriately addressed in the design and evaluated in testing. The FDA requested that the client conduct another human factors study that addressed these concerns, validating safe and effective use of the device by intended users.
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Medical Devices | UDI | MD&M East | md&m | Conferences

4 Things R&Q Learned At MD&M East

What an action-packed three days MD&M East was this year! Our team is exhausted, but in the absolute best way possible. I'm not sure how anyone who attended the show could've escaped the exhaustion... as the exhibit floor was BIG. If you're reading this and attended, hopefullly you found the conference worthwhile. We certainly did. Here are four things we learned this year.
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Medical Devices | OSA | Clinical Studies | medicaldevice | Sleep apnea

This New Med Device Will Help You Sleep Better

Everyone appreciates a good night's sleep. A big obstacle to that is the fact that 18 million American adults suffer from Obstructive Sleep Apnea (OSA), and the condition arises simply from a wayward throat muscle. A new study by Dr. Richard Schwab, co-medical director of the Sleep Center at the University of Pennsylvania School of Medicine, shows how a new technique that can correct the issue.
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RAPS | industry guidance | regulatory news | regulatory | Industry Advice

Industry Advice: Earn RAC Points and Enhance Your Resume by Writing for RAPS' Regulatory Focus

You've already read a few benefits in the title but let's reiterate: Earn RAC points Enhance your resume/LinkedIn profile Get published, and share your expertise with industry peers in the process These are just three of the several reasons you should consider writing an article for RAPS' Regulatory Focus. Don't sweat it if writing isn't your forte - there's nothing to be afraid of. The editorial board is there to you help you bring your ideas to life (and correct all those grammatical and punctuation errors). And once you get started, the entire writing process usually takes less time than you think. RAPS is looking for authors for the September and October 2016 issues of Regulatory Focus. Or... maybe you have an idea for an article that could appear in any issue? Either way, now is your chance and here are more specific details.
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R&Q | Careers

R&Q Q&A: Boston Employee Spotlight

Welcome to the first post in our R&Q Q&A series. Every two months we'll ask R&Q employees from a different region questions about how they make their impact at R&Q... and the impact R&Q has had on them. From improving people's lives to R&Q's corporate culture, we hope their answers shed light on how R&Q influences the medical device industry and why our employees claim working at R&Q is a highly rewarding experience. Visit our Careers page to view current openings.
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3d printing | medical device | meddevice

The Med Device Industry (and the FDA) Embrace 3D Printing Innovation

Just this week the world's first 3D-printed office opened in Dubai. It took all of 17 days to print a 2,700-square-foot building at half the price of conventional methods. In short, this 3D printing thing has some legs... and we mean that literally, too. 3D printing is definitely a hot topic across the medical device industry. This ground-breaking technology that began in the 80s has advanced into a valuable tool for manufacturers, and even earned itself draft guidance from the FDA earlier this month.
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Engineered By Women | entrepreneurship

R&Q: Engineered by Women

Did you know that women are half as likely as men to start businesses? That's a statistic R&Q wants to help change. Aside from the importance of gender and fairness issues, women entrepreneurship fuels economic growth. R&Q is Engineered by Women. We're proud to have been started and now led by our female co-founders and owners, Maria Fagan and Lisa Casavant. What they've accomplished and continue to accomplish over the course of their careers prove they are driven, visionary, and immensely influential in the medical device industry. They most certainly have been positively influential to R&Q's medical device clients. Since the LLC was formed in July of 2008, Maria and Lisa's mission has centered on customer and employee satisfaction. This has helped us grow to more than 70 QA/RA professionals - including former FDA staff and 25+ year industry veterans - and establish a corporate culture in the device industry that we think is second to none.
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UDI | massmedic

A Whole New World of UDI: Slides and Recording

If you have any UDI needs or questions, do not miss this post.
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medtech | md&m | Conferences

MD&M East Expo and Conference: June 14-16

Be a part of the largest and most influencial medical manufacturing event on the east coast. Join more than 500 leading medtech suppliers and manufacturers - including Johnson & Johnson, Stryker, and countless others - at the Medical Design & Manufacturing (MD&M) East Expo and Conference, June 14-16 in New York City. Needless to say, the R&Q team wasn't going to miss this and we'll be on hand at booth 1164 and ready to listen to what's happening at your organization.
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FDA | PA Bio | Philadelphia | Pennsylvania

Presentation and Networking at PA Bio: Practical Considerations for Avoiding FDA Compliance Problems (BEING RESCHEDULED)

NOTE: This event has been cancelled and is being rescheduled. Organizer Regulatory and Quality Solutions (R&Q) What? A presentation and networking event over lunch at PA Bio: Practical Considerations for Avoiding FDA Compliance Problems, and How to Manage Them If They Arise   In the session you will learn from a former FDA consumer safety officer of 20 years what it takes to proactively improve your systems to avoid problems, and proficiently manage issues if they happen to occur. First-hand experiences of how R&Q helped remediate projects will be shared, and best practice strategic and tactical solutions will be given for how to avoid those situations in the first place. We’ll also investigate emerging oversight trends, common problems, classic times in business cycle when compliance issues arise, and other specific challenges.
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iso 13485

The New ISO 13485 Standards are Here! Sign Up for a Free R&Q Webinar

The world's most well known standards for medical device quality management have been updated for the first time since 2003. Released in March by the International Organization for Standardization, ISO 13485 provides the universal requirements for manufacturers and service providers to comply to regulatory requirements. The standards aim to establish consistent processes for medical device design, progression, installation and distribution, focusing on the safety of the total life span of the device. Some of the essential changes: Globally aligning regulatory requirements Applying risk management practices throughout the quality managment system Attention to supplier sourcing and selection Supplemental requirements for design activities, such as validation and verfication More specific requirements for Design and Development, Corrective Action and other applications Required Medical Device File to validate compliance to new standards  The standards must be adopted by 2019, which could prove to be a difficult task for manufacturers. Commencing adoption sooner rather than later will aid a steady transition, and that's why we're hosting a free webinar.
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human factors | advamed | design controls

AdvaMed Workshop: Integrating Human Factors into Med Device Design Control and Beyond

Attention any and all regulatory affairs specialists, engineering managers, quality & production engineers, QA/Q directors and managers and compliance officers: AdvaMed is presenting a Design Control-focused workshop in Golden Valley, Minnesota, June 7-8. The workshop has been pre-approved by RAPS as eligible for up to 9 credits towards a participant’s RAC recertification upon full completion. R&Q's Bob Marshall (pictured) and Ryan Kasun will be on hand to present. Read on for more details and to register!
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FDA | compliance | UDI | massmedic

MassMEDIC Webinar: A Whole New World of UDI - May 18

If you missed R&Q's Paul Robinson discuss UDI during R&Q's afternoon workshop at BIOMEDevice in April, here's a second chance. A similar presentation and discussion will be offered in conjunction with MassMEDIC on Wednesday, May 18th at 11:30am EST. All the details - including the link to register - are below!
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PA Bio

PA Bio Connect@ - May 9 in Philadelphia

Great news, Philly! EisnerAmper will be hosting the Pennsylvania Bio: Connect@ Series May 9th in Philadelphia - and we'll be there. R&Q is a longstanding member of Pennsylvania Bio and is excited to network at this event and other upcoming events in the area, too. Here's what to expect...
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FDA | compliance | advamed

AdvaMed Webinar: Avoiding and Managing FDA Compliance Problems - Monday, May 9th

Did you miss former FDAer Jake O'Donnell speak about avoiding and managing FDA compliance problems during R&Q's afternoon workshop at BIOMEDevice earlier this week? If so, we have news especially for you: he will be presenting on a similar topic via a webinar on Monday, May 9th at 1:00pm EST. The webinar is presented through AdvaMed, and all the details - including a link to register - are below.
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inspection | fda inspection | FDA | white paper | compliance

NEW White Paper - Practical Considerations for Avoiding Regulatory Escalation: R&Q's Latest, In-Depth White Paper from a Former FDA Consumer Safety Officer

There’s a formula for effectively managing an adverse FDA inspection and the newest R&Q white paper shares it. Learn all the practical considerations for avoiding regulatory escalation from a former FDA Consumer Safety Officer: R&Q's Jake O'Donnell. This is your free, ultimate compliance resource, that you can download now: Managing An Adverse FDA Inspection: Practical Considerations for Avoiding Regulatory Escalation. Preview the first four pages of the 24-page white paper below (click to enlarge), and download it in its entirety at the link! We hope you find the white paper valuable. If you do, be sure to share it with your colleagues and industry peers. Subscribe to R&Q's Blog to stay updated on when new white papers and other content is available.
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Minnesota | Medical Alley

Minnesota, Here We Come: See You at the 2016 Medical Alley Annual Meeting, April 27th

R&Q will be a Supporting Sponsor at the Medical Alley Association's 2016 Annual Meeting, April 27th. If you're not familiar, the association is a state-based member organization servicing the health technology community who works to promote Minnesota's Medical Alley by influencing policy at the state and federal levels. R&Q's Lisa Casavant (Cofounder/VP) and Juli Denny (VP Sales and Marketing) will be onhand so keep a look out for them and our exhibit table at the event. If you'd like to schedule specific time with us before or after the event, contact us to let us know.
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IVD | compliance | UDI | Boston | IVDR | BIOMEDevice | Workshops

R&Q's Can't-Miss Education Event of the Year: An Afternoon Training Workshop at BIOMEDevice in Boston, April 13th

Those in the northeast, get ready! Not only will R&Q be exhibiting at this year's BIOMEDevice show (booth 640) and sponsoring MassMEDIC's Annual Conference, but we'll be presenting an afternoon training workshop (three separate sessions) free to attendees of the BIOMEDevice show on Wednesday, April 13th from 1:00 - 4:00pm. The event will cover compliance, IVDR, and UDI... and you can choose to attend whichever session(s) you like. This will be one of R&Q's premier education events of the year and we're incredibly excited about the team we'll have on hand to share their expertise and experience, moderate discussion, and field questions. Keep on reading for complete details.
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Clinical Studies | Case Studies | Clinical Evaluation Report

When Benefit Outweighs Risk: Creating a Successful Clinical Evaluation Report - A Case Study

About R&Q's Case Studies: We hope you enjoy our third case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available.   Challenge High volume of data... and differing opinions. A client's product is utilized on critically ill patients in intensive care units. As a result, comorbidities and adverse events during the use of the device are inevitable. There were more than a thousand customer complaints and hundreds of serious adverse events reported to public databases for the subject device and comparative devices. Notified body findings on the previous clinical evaluation reports and internal conflict over the requirements added to the confusion.
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regulatory strategy | Case Studies

5 Heads are Better Than 1: De-Risking Your Regulatory Pathway Using a Team Approach - A Case Study

About R&Q's Case Studies: We hope you find value in our second case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available.   Challenge Regulation doesn't have to be a barrier to innovation. A client was developing a software package using Big Data to provide clinical decision support for physicians. They initially believed a premarket approval (PMA) could be required for the product depending on the claims that would be made. They were also concerned about the potential cost of clinical trials and the overall timing of bringing the product to market.
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remediation | Case Studies | Design History File Remediation

Introducing Our First In A Series of New RQM+ Case Studies: Design History File Remediation

About RQM+ Case Studies: Our goal in producing case studies is to succinctly demonstrate how RQM+ applied our unique expertise to tackle a client's challenge, implement a competent solution, and demonstrate real results. We will post each case study to our blog and offer a downloadable PDF as well, perfect for printing and/or emailing to colleagues and industry peers. Our first case study focuses on Design History File Remediation and we hope you enjoy it. The content of future case studies will be around the services RQM+ offers, including areas of regulatory, quality systems, design assurance, product quality, and post-market surveillance - particularly remediation. Subscribing to our blog is the best way to know when future case studies are available. View all of our available Case Studies.
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FDA | Ohio | BioOhio | Regulatory 101

Announcing the 2016 FDA Regulatory 101 Series

Medical device professionals in Ohio, are you ready? Last year R&Q teamed with BioOhio to present an ongoing series of 101 medical device events throughout the year. Thanks to participation and feedback from ambitious medical device professionals across Ohio - and the support of our gracious hosts - the events were a success. Because of that, we're thrilled to announce we'll be presenting a new and improved program in 2016! One webinar and three in-person events are on tap for this year, with the first - a webinar on medical mobile apps - scheduled for March 3, 2016. Register for the webinar and see the list of upcoming FDA Regulatory 101 events below.
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510(k) submission | 510(k) review | 510(k) | advamed | Workshops | Education

Hear R&Q and Other Industry Experts Discuss 510(k) Submissions at AdvaMed's Workshop In Irvine, CA

Join R&Q's Marilyn Waxberg and Nancy Morrison as they speak along with other industry experts at AdvaMed's 510(k) Submissions Strategy Workshop in Irvine, CA this month. The event is scheduled for two days: February 22-23. Marilyn is R&Q's Senior Principal Advisor and Nancy is Director of Regulatory Affairs. Nancy will be speaking to The Law and Regulations portion of the agenda alongside Pamela Forrest of international law firm King & Spalding. Both Marilyn and Nancy will be leading the Strategy and Planning section on day two.
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Medical Devices | CT Scanner | Creativity | New York

Revisiting a Classic: The Pirate-Themed CT Scanner

Behold medical device ingenuity at its finest. In 2013 the NewYork-Presbyterian Morgan Stanley Children's Hospital purchased a pirate-themed CT scanner, and the result is an incredible way to put children at ease before being scanned. See the rest of the creativity in pictures below.
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M2D2 | UMass | Boston

R&Q Is Sponsoring The M2D2 $100K Challenge and A Summary of Important Dates

The University of Massachusetts Medical Device Development Center (M2D2) has announced the M2D2 $100K Challenge 2016, a nationwide competition that showcases innovative ideas of early-stage medical device, diagnostic, and biotech companies. R&Q is proud to announce that we are one of several sponsors who will award up to a total of $100K in services (we're also a Platinum Sponsor of M2D2 in general). Winning companies can receive use of the facility's lab and office space, along with engineering, legal, regulatory, clinical and business services.
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Combination Products | Boston

Presentation and Networking: Is A Medical Device Hiding In Your Product Portfolio? Join R&Q at MassBio!

Organizer Us! Regulatory and Quality Solutions (R&Q) What? A presentation and networking event over lunch addressing how an accessory or tool, in reality, is often a medical device.   This session will discuss combination products and the use of accessories with drugs and biologics. We will review examples of product types that may not be obvious and also what to watch out for during the development process. Finally we'll look at some MDR examples where the device types were not initially disclosed or identified correctly.
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Medical Devices | News | FDA | R&Q

Announcing R&Q's Newest Senior FDA Compliance Principal: Former FDA Consumer Safety Officer Jake O'Donnell

R&Q is thrilled to announce the newest member of our team. Jake O'Donnell will act as Senior FDA Compliance Principal beginning February 2016. Jake formerly acted as Consumer Safety Officer (CSO) at the FDA for 20 years.
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Medical Devices | R&Q | Video

We Made a Video About R&Q! Here's Why.

One of R&Q's priorities in 2015 was to find new, distinctive ways to tell our story. We wanted to make it abundantly clear to potential clients and employees that R&Q is first and foremost about improving lives. We also wanted to clearly explain how we improve lives. The result of our brainstorming was to create a short video that takes the viewer through the journey of how R&Q helps our clients - from start to finish.
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News

Welcome To R&Q's New Website!

Welcome to R&Q's updated website! To state it plainly, we've revamped our website to better serve the needs of regulatory and quality professionals in the medical device industry. We hope you find it easy to use. Some changes include more clearly outlined services, additional detail on the white papers we offer, and a video that tells the story about how we help our clients, as seen below. You'll notice that the video is the first call-to-action on our homepage, just under, "We help get medical devices to market faster. And keep them there."
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Notified Body Expectations: Today, Tomorrow and into the Future

  R&Q and Nerac invite you to attend a free medical device event and panel discussion titled:   Notified Body Expectations: Today, Tomorrow and into the Future   Space is Limited - Register Today https://www.regonline.com/builder/site/Default.aspx?EventID=1718288 Thursday, June 18, 2015 7:30am to 11:00am (EST) Embassy Suites Waltham, Waltham, MA
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Ten Tips for A Successful Use of Total Product Life Cycle (TPLC) Reports

The FDA, as part of the transparency initiative, has developed a Total Product Life Cycle (TPLC) report capability on their website (www.fda.gov). The intention behind this new report is to provide existing data to medical device manufacturers that will enable them to proactively address quality related issues as early as possible. The TPLC database allows users to search by type of device (product code) and provides a report that identifies the related 510(k) clearances for that particular product code, recall reports, and medical device reporting (MDR) information for the product code selected. What does that mean? Ultimately, companies should have quality systems that incorporate TPLC information into all aspects of their system; such as supplier qualification/monitoring, risk management, design controls, corrective and preventive action, and complaint handling. Incorporating this information throughout the entire life cycle of the device will bring devices to market more efficiently and with less issues post-launch.
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Ten Tips for Successful Integration of Risk Management & Usability Engineering

Even though Risk Management and Usability Engineering are clearly two separate processes with unique requirements, they are interdependent and must communicate with each other during the entire product lifecycle. Risk Management identifies the risk of a medical device’s potential hazards and provides input to the design requirements. The process determines the likelihood and severity of those potential hazards, analyzing the device’s design, function and manufacture. Usability Engineering identifies and assesses risks associated with using the device. Controls used to develop product and usability specifications are established to mitigate the associated risks. The user interface, operation manual and/or instructions for use play key roles in Usability. Together, they help to ensure safe and effective medical devices are brought to the market. Their implementation takes time and effort, but is well worth the investment if field issues are mitigated.
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510(k) Submissions-Ten Tips for a Successful Submission

The process of submitting a 510(k), demonstrating that your device is substantially equivalent to a device that is already cleared, can be daunting. Typically designed to be a 90-day review by the FDA, the entire process could take several months if adequate information is not supplied to the FDA. Their requests for additional information need to be met satisfactorily and in full, or you risk delaying your release schedule and going into a total of three rounds of questioning. If you have not adequately addressed the FDA’s concerns after three rounds of questions, your device will be found not substantially equivalent (NSE) to the predicate device(s). Ideally, you’ll avoid rejection and an NSE letter, and your device will gain clearance into the market, keeping your release on schedule and your investors happy.
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Successful Regulatory Strategy-Ten Tips

Having a documented regulatory strategy developed early during a new product’s development life cycle and updated periodically is critical for a new product’s market success. An inaccurate or lack of regulatory strategy can lead to the product not being cleared for market in the desired countries, not being released to market on time because of regulatory hiccups that were not anticipated, and/or being released to the market with inadequate claims such that the product does not fulfill the need of the target market, thereby not selling. Many times during development there are disconnects between marketing expectations and engineering development plans. A thorough regulatory strategy will not only document the regulatory pathways, but also align the new product development team on critical product requirements (intended use, claims, indications, release countries, etc.) and tracks risk items for the selected regulatory pathways. A regulatory strategy is one location where these items can be aligned on at least at the highest product requirement level to ensure a smooth start for development. Periodic updates are very important. When changes are proposed in design, intended use, or claims or changes occur in the regulatory environment, an update to the strategy and proactive communication to the product development team will maintain alignment of the regulatory activities and business strategies, creating an efficient pathway to market.
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CAPA - Best Practice Sharing

Healthy CAPAs = Competitive Advantage
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Implementing a Successful Recall Process - Ten Tips

In the medical device arena, recalls are a fact of life and competitors love to find out that you’ve had one. Regardless of recall classification (Class I, II, or III), a recall procedure is instrumental in working in concert with a company’s post-market surveillance and agreements with suppliers. Companies should not assume there is never going to be an issue with a product and not have these procedures in place up front.
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Warning Letters - Ten Tips

Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the agency’s good graces and through the experience develop processes that result in better business both culturally and financially. But getting to that point may be a slippery slope if the issues in the letter are not addressed effectively and expediently.
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Q-Sub | FDA | Guidance Document | Pre-Sub | PMA | 510(k) | Pre-Submission

Pre-Submission Program – Final Guidance

On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA prior to the submission of a premarket application (PMA, 510(k), HDE, IDE, de novo, etc.). The sponsor may submit a pre-submission application to the FDA requesting answers to various questions about the marketing application or clinical trial design of their device. The sponsor may request a written response, teleconference, or meeting. The FDA has committed respond to the sponsor within 75 to 90 days.
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Affordable Breakthrough Innovations

Innovative ideas for medical devices are often costly for manufacturers to make and for patients to own. However, not all innovative medical devices will cost you an arm and a leg.
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guidance documents | 23andMe | FDA | Custom Device Exemptions

Guidance Documents for 2014

In an effort to help get safe and effective medical devices to market more quickly, the FDA publishes a list of proposed guidance documents each year. Here is FDA’s prioritized list of things you can expect to see in 2014:
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FDA | medical device | PMA

Pediatric Subpopulations – Final Rule

On Friday, January 10, 2014 the FDA issued a final rule, which amends the premarket approval (PMA) regulations. The final rule requires “submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat”. 1 The final rule also defines “pediatric patients” and “pediatric subpopulations”. Per the final rule, “pediatric patients” is defined as a patient who is 21 years old or younger at the time of treatment or diagnosis. “Pediatric subpopulation” means on for the following populations: neonate, infants, children, or adolescents.
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FDA | 510(k) review | 510(k) | CDRH

510(k) Pop Quiz!

How well do you know the logistics of the 510(k) process? Today’s blog is interactive, as well as educational! Take this quiz (no cheating!). Comment on the post to tell me how many answers you got right!
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3D Printing in Medicine

As if 3D printers for rapid prototyping weren’t cool enough, researchers at the University of Wollongong and St. Vincent’s Hospital Melbourne, part of Australian Research Council Centre of Excellence for Electromaterials Science (ACES), have been using 3D printing to make some pretty exciting advances in tissue engineering and orthopedic surgery.
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Regulatory News - Report on FDA Device Review Process

As part of FDA’s Performance Goals and Procedures adopted under MDUFA III (The Medical Device User Fee Act of 2012), the FDA agreed to participate with the medical device industry in an independent assessment of the process for the review of medical device submissions. The key objective of this task was to develop a set of recommendations for FDA to implement with the potential to have a significant impact on review times. The recently released report, prepared by Booz Allen, identifies four broad areas where the agency should improve its methods for premarket review of medical devices:
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Transhumanism | Transhumanism - Science from Fiction

Transhumanism - Science from Fiction: Conclusion

Trans∙hu∙man∙ism /tranz’hyoomənizm// Noun The belief or theory that the human race can evolve beyond its current physical and mental limitations, especially by means of science and technology.1  
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Medical Devices | military

Devices for the Military

This past weekend I travelled to the Chicago-land area to attend my brother’s graduation from Northern Illinois University and commissioning into the US Army. He will be reporting to Fort Leonard Wood, Missouri for officer training as part of the Army Corps of Engineers. This has been a very proud and exciting time for all of us.
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Veterinary Medical Devices - FDA Regulations

I recently worked on a project that involved writing a regulatory strategy for a device used on animals. This was a new area for me and I got interested in learning even more about the topic afterwards. I was curious as to how big of a market veterinary devices were, as well as what type of regulations were around developing and selling devices for veterinary use.
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Transhumanism | Transhumanism - Science from Fiction

Transhumanism – Science from Fiction: Part III – Not So Vulcan Mind Melds

Not So Vulcan Mind Melds
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Getting to Know You

You probably think you know yourself pretty well, right? Of course. You’re a (circle all that apply) super cool/ witty/ charming/ good-looking/ intelligent person, and humble about it too, but what does your DNA say about you? DNA is an incredibly complex storage structure for information about us – genetic information about how we develop and function, who we physiologically are and have the potential to become. So much of that information is a mystery to us, but what if it wasn’t? What if you knew all of the traits you carry and where they came from, how your body would respond to any medication, and what health conditions you are predisposed to encounter? It would be incredibly useful (not to mention extremely interesting) to discover all of this about yourself, although I have a feeling that a large percentage of the population would turn hypochondriac.
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Transhumanism | Cyborg

Transhumanism - Science from Fiction: Part II - Rise of the Cyborg

The Cyborgs Are Coming!
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Devices remain unclassified

I read a really interesting article this week written by Josh Rising called "The Loophole That Keeps Precarious Medical Devices in Use". The articles explains how when the Medical Device Amendments of 1976 were implemented, dozens of marketed medical devices were left unclassified. The 1976 Amendments immediately took actions on newly developed devices and classified devices already on the market as "medium-risk" devices until the FDA could take the time to evaluate the real risk of those devices on an individual basis.
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culture of quality | quality

A Culture of Quality

As quality professionals, we are always looking for ways to improve the quality of products, and reduce the cost of quality mishaps. But how do you actually climb to the top of that mountain of high quality while still maintaining a marketable product?
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Not-So-Blind Ambition

Can you imagine what a GPS for blind people would be like? We may not be there yet, but a research project at the University of Arkansas could be the next best thing. Dr. Cang Ye and his team are making over the standard white cane often used by the visually impaired into a high-tech portable navigation device using sophisticated laser technology. They are incorporating a 3D imaging sensor system called Flash LADAR (laser detection and ranging) into the cane, which will inform the user of key environmental factors such as possible obstacles.1
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RAPS 2013 Series: MDSAP

Of all of the seminars I attended at the RAPS 2013 Conference in Boston, the Medical Devices Single Audit Program ("MDSAP") was arguably the best. The overview of MDSAP - done well by Kim Trautman of the FDA and Mike Ward from Health Canada - was thorough and well done; however, it was the overall conclusion and closing remarks from Elisabeth George of Philips Healthcare and Paul Brooks of BSI that made this an engaging session.
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Quality Control for Blood Transfusions

Over the years, major advances in blood transfusion safety measures have drastically reduced the risk of viral transmission via allogeneic blood. Although correlation doesn’t necessarily imply causation, it’s tempting to believe that this may have something to do with the thriving, pervasive (and quite frankly, annoying) presence of vampires in contemporary pop culture, but that’s a topic for another day. Since this reduction in viral risk, the greatest residual threat of disease transmitted by blood transfusion is bacterial contamination.1
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Diabetes | Artificial Pancreas | FDA | Artificial Organ | PMA

First Artificial Pancreas receives FDA Approval

Upon my nightly adventures of surfing the World Wide Web I came across this article on the Popular Science website announcing the FDA’s approval of the Medtronic MiniMed 530G Insulin pump, praisingly dubbed the first artificial pancreas. The Medtronic device was officially approved by the FDA on September 26, 2013 through the Premarket Approval (PMA) pathway. According to the FDA Approval Letter the MiniMed 530G System is intended for continuous delivery of basal Insulin (at user selectable rates) and administration of Insulin boluses (in user selectable amounts) for the management of Diabetes mellitus in persons, sixteen years of age and older, requiring Insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 530G System can be programmed to automatically suspend delivery of Insulin when the sensor glucose value falls below a predefined threshold value.
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medical device manufacturers | device manufacturers | Affordable Care Act | medical device news | Medical Device Tax

On the Edge of Our Seats

As the government shutdown dragged onward, nobody was watching the outcomes more than medical device manufacturers. For device manufacturers – there was and still is a lot at stake. And make no mistake – the medical device tax is part of the hot debate in Washington right now. Part of the 2010 Affordable Care Act included a 2.3% tax on medical devices. The tax has caught a lot of attention from both Republicans and Democrats – part of the most recent House GOP proposal to end the partial government shutdown actually includes a deal to suspend this medical device tax for two years. The revenue from this tax is to be utilized to help fund the Affordable Care Act. The tax has not been fully supported by either party – back in 2010, 30 Democrats joined Republicans and opposed the medical device tax. However, there are very worthy arguments against the device tax & defending the device tax, which I will not explore in this article but are referenced on Newsreplubic.com. (Source: News Republic “Is Obamacare’s Medical-Device Tax Up for Negotiation?”) Why hasn’t the tax been nixed in general you might ask? Mainly, we haven’t found an alternative source of tax revenue that would replace what the medical device tax would provide, as it raises approximately $30 billion over 10 years and is a large part of the funding for the Affordable Care Act. In most recent news (Late Tuesday, 10/15), the tax has been cut from the latest House Republican offer; meaning the two year delay might be scrapped altogether. However – it has been in and out of several offers from both Republicans and Democrats for the last several months. (Source: The Washington Post “GOP leaders nix medical device tax delay”). As of this most recent news – it is not looking good for device manufacturers as far as delaying the tax; however, as we’ve already found out – a lot can change in a short amount of time. -SJG
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Medical Devices | Artificial | Larynx | cancer | Clinical Studies

Deep Breaths

The standard treatment for patients with cancer of the larynx is to have a tracheostomy tube installed. Tracheostomy tubes are Class II devices, under 21 CFR 868.5800. According to ProTip CEO Maurice Beranger, this technology has not changed in 140 years. Tracheostomy tubes impair a patient’s ability to breathing through the upper airway and talk normally.
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Government Shutdown - Impact on Medical Devices

On October 1st, 2013, the Government of the United States began shutting down operations due to an impasse in congress regarding government funding appropriations. Practically speaking for the medical device industry, the shutdown puts businesses, medical professionals, and, ultimately, patients in a lurch as new medical technology cannot get to market.
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Bionic | Transhumanism - Science from Fiction

Transhumanism - Science from Fiction: Part I - Bionic Body Parts

Advancements in biotechnology have made things of science fiction into reality. Back in the 70’s, bionic body parts were thought to be donned only by the Six Million Dollar Man1 and The Bionic Woman2. Fast forward forty years and bionic body parts are more science than fiction. As LiveScience.com said, “Scientists are getting closer to creating a bionic human, or at least a $6 million one.”3
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Telehealth

In the world in we live, where communication is becoming further removed from face to face interaction, medicine is utilizing telecommunications technologies to advance treatment and care for patients.
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FDA | medical device | Risk-Benefit | Patient Preference

FDA gives Voice to the People

The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has launched a new initiative targeted at giving the patients a voice in the agency’s decision making process on medical devices. I became aware of this effort by the FDA when recently reading this article which describes CDRH’s program called Patient Preference Initiative.
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RAPS 2013: Education Series

Last week, R&Q attended the RAPS 2013 Conference held in Boston, MA. We were thrilled with the event - a big "Thank You" is due to RAPS for putting on such a great event. A few of our team members were granted the opportunity to attend the seminars that RAPS arranged to allow regulatory professionals opportunities to continue their career development path, or simply keep up to date with current events. R&Q is dedicated to the same goals as well. As a result, check-in with our blog over the next few weeks as we recap some of the more critical updates from RAPS and expound on any further developments since the conference. Happy reading! -RTK
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Canada | change in contract manufacturer | health canada | medical device | license amendment fax back form | registration triggers | registration | change in country of origin

License Amendment Triggers in Canada

Sometimes changes in process can have a dramatic effect on product registration. There are several events that can cause a re-registration of a registered medical device. A new product name, part number, material, manufacturing site, country of origin, business name or manufacturing process are common re-registration triggers. It all depends on the specific regulations of the country involved.
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Medical Devices | artificial knee | running | biomechanics

Pounding the Pavement

Earlier this year I joined a running club, Steel City Road Runners (come run with us!). I’m still a newbie, but I really enjoy the challenge that running provides. This past week, the Boston Marathon announced to applicants who would be awarded the last 5,000 spots in the 2014 Boston Marathon. It was really inspiring to see many of the people in my group be awarded these spots, I know how hard they have worked, and I’ve pounded the pavement with them more than once.
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R&Q at RAPS 2013!

Good morning!
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FDA Releases Mobile Medical Applications Guidance Document

This week must be the week of the FDA publications. In the same week the UDI final rule and guidance were published, the FDA has also released the guidance document on the FDA's plan for enforcement regarding Mobile Medical Applications. The FDA's final thoughts on how they'll regulate mobile medical applications will likely surprise many of their critics.
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Retraining the Brain – A New Approach to Treatment for Schizophrenia

Schizophrenia is a debilitating neurocognitive disease that affects about 2.4 million people in the United States alone.1 Schizophrenic patients exhibit impaired working memory, attention, problem solving capabilities, and general social functions. Frequent negative hallucinations and delusions coupled with the inability to think clearly often lead them to lose their grip on reality, increasing the likelihood of suicide attempts in this group to 40 times that of the general population.1 Traditionally, physicians have prescribed various antipsychotic medications to keep the hallucinations and delusions under control, although the underlying disordered cognition remains untreated. However, Pitt assistant professor of social work and psychiatry Shaun M. Eack and his colleague, physician Matcheri Keshavan, are investigating an exciting nondrug therapy intending to rehabilitate schizophrenic patients by enhancing their cognition, essentially retraining their brains.1 Eack and Keshavan are continuing innovative research started by Gerard Hogarty, the late professor of psychiatry at the University of Pittsburgh School of Medicine. Hogarty was known for his use of Cognitive Enhancement Therapy (CET), originally used for rehabilitation of people with traumatic brain injuries, to improve cognition in schizophrenic patients.1 CET mainly involves computer-based exercises that leverage the brain’s neuroplasticity to improve the cognitive functions in which schizophrenics are deficient.1 Initial research has displayed promising results – neuroimaging scans of patients’ brains after CET showed decreased brain atrophy and increased growth of new brain tissue compared with brain scans before CET.1 This groundbreaking research produced the first evidence of a clear structural neurobiological effect on schizophrenic patients’ brains by a nondrug treatment.1 Initial study participants also saw improvements in social functions, task performance, work readiness, and general activities of daily life. While the research is still ongoing to gather additional evidence of the therapy’s effectiveness, the initial results indicate that there is hope for those suffering from schizophrenia to regain cognitive abilities and see functional improvements beyond those afforded by traditional drug treatments. -KB Image credit: Life Mental Health @ Flickr 1 Levin, Steve. "Think Again." Pitt Magazine Fall (2013): 18-21. Print.
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UDI Documents Released by FDA

The rule and guidance document for Unique Device Identifiers ("UDI") on medical devices and some combination product that contain devices has been released.
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EU marketing approval system

The European marketing approval system for medical devices is less stringent than other regions of the world and because of that, at times it is viewed as a more attractive market for device manufacturers. However over the past few months, a new proposal has come up in Europe that could drastically change the approval process.
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Regulatory and Quality Solutions | RQS | regulatory | Regulatory Pathways

Same Road (Regulatory Pathway), Different Car (Medical Device)..Similar Success (Clearance,Approval)

As you might expect, here at RQS the responsibilities and duties of providing our clients with the support they need often involves traveling for on-site visits. For the time being, most of the travel takes place within the greater metropolitan area of the cities in which we currently have offices: Cleveland and Pittsburgh. Our Pittsburgh team makes rounds to their Pittsburgh-based clients and our Cleveland team makes rounds to their Cleveland-based clients. However, in order to best meet our clients’ needs, there is a fair bit of interchanging resources between our offices. Employees, some more than others, travel within the two metropolitan areas providing support to clients in both regions, as needed. Having been one of our Pittsburgh-based employees who has frequently traveled to Cleveland for client support, I thought I would use this blog post to reminisce on the journey.
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Transhumanism | Transhumanism - Science from Fiction

Transhumanism - Science from Fiction: Intro

What do Jean Grey and Professor Xavier of X-Men, Vulcan “mind-melds” from Star Trek, the Six-Million Dollar Man, Darth Vader and Jedi mind tricks from George Lucas’ Star Wars, The Bionic Woman adapted from Martin Caidin’s Cyborg, Inspector Gadget, Replicants from the 1980’s movie Blade Runner, and Neo (along with his comrades) from The Matrix, all have in common?
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International Labeling Requirements

It used to be much easier to have an international device on the market that complies with the regulations of the multi-country international market. With a properly localized multi-language Instructions for Use, the regulations of most international countries were met with one finished good. However, international regulations are becoming increasingly complex. In addition, more and more countries have difficult labeling requirements that are specific to their country.
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Brain disease | iso 14971 | risk management | Harm | Sequence of Events | Hazardous Situation | sterilization | Hazard

Foreseeing the Risks

On the news this morning, I heard a story that got me thinking about risk management. The headline was “Eight N.H. patients possibly exposed to fatal brain disease”. Further research about the situation reveals just how complex this case is.
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510(k)

510(k)-Exempt Devices

In the FDA-regulated medical device world, there are 3 classifications for medical devices: Class I, Class II and Class III. The FDA (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm) provides a rather in-depth overview of how to classify a medical device and the requirements behind each product's classification. What may not be evident, or often discussed in common conversation, is that many Class I and some Class II medical devices are 510(k) exempt.
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Personalized Orthopedics

As part of a growing trend toward personalized healthcare, the medical device community has contributed “cutting edge” technologies enabling a variety of custom orthopedic procedures. Let’s take a look at a couple of the players! One exciting new development in customized orthopedic implant procedures is the 510(k) clearance of Zimmer’s Patient Specific Instruments Shoulder device in August.1 This system works in tandem with Zimmer’s Trabecular MetalTM Reverse Shoulder base plate implant system in reverse shoulder arthroplasty procedures, using 3D visualization software to enable surgeons to create patient-specific surgical plans and corresponding surgical instrument guides.1 In addition, Zimmer’s ContinuumTM Acetabular System provides surgeons with the ability to customize hip implants with the load bearing technology best suited to each patient.2 Late last year Pittsburgh’s own Blue Belt Technologies received FDA 510(k) clearance for its NavioPFS™ robot-assisted orthopedic surgical system.3 In June the company also gained clearance for the STRIDE™ Unicondylar Knee implant system, which is meant to be used with the NavioPFSTM system in personalized, minimally invasive, partial knee replacement procedures.3 I may be 27, but my joints already don’t move like they used to! It’s encouraging to see advances in medical technology that personalize orthopedic implants to the needs of patients and minimize the impact to their daily lives. -KB Image credit: Libertas Academica @ Flikr 1 Zimmer Holdings, Inc. Zimmer Receives FDA Clearance For Patient Specific Instruments (PSI) Shoulder. -- WARSAW, Ind., Aug. 23, 2013 /PRNewswire/ --. PR Newswire, 23 Aug. 2013. Web. 02 Sept. 2013. 2 Zimmer Holdings, Inc. New Hip Implant Provides Personalized Fit. -- WARSAW, Ind., March 11 /PRNewswire-FirstCall/ --. PR Newswire, 11 Mar. 2010. Web. 02 Sept. 2013. 3 Simmons, Abby. "News Brief: Carnegie Mellon Spinoff, Blue Belt Technologies Inc., Receives FDA Clearances-Carnegie Mellon News - Carnegie Mellon University." Carnegie Mellon News (25 June 2013): n. pag. Carnegie Mellon News. 25 June 2013. Web. 02 Sept. 2013.
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FDA guidance document on RF Wireless Technology in Medical Devices

With the growing use of incorporating wireless technology into medical devices, the FDA has issued a final guidance Radio Frequency Wireless Technology in Medical Devices. This guidance document is meant to cover a wide range of medical devices that use wireless technology from imaging and systems used in a hospital or clinical setting to devices implanted or applied directly on the patient's body. The guidance document recommends certain design control and testing measures as well as post-market maintenance monitoring that can be taken in order to ensure safety to the patient.
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Improved machines based on human biology

Today, when I was thinking of a blog topic, I had a moment of clarity. I realized that I regularly peruse the news and media for evidence of how machines and medical devices help humans, improve human life, and how humans utilize machines and technology to help solve problems. I also realized that I rarely I encounter a news article that discusses how something was improved upon, by being modeled after a human or a biological human factor.
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Genome | Medical Advancement | HeLa | Henrietta Lacks

Recognition for Contributions in Medical Advancement 60 years in the making

In my Bioethics course during my undergraduate years, we had discussed the curious case of Henrietta Lacks: a 31 year old African American mother who contributed to numerous modern day medical advancements upon her death without her or her family’s knowledge. I noticed that Henrietta’s story was currently in the news and learned that from these New York Times articles ( here and here) that she had finally (somewhat) been given credit for her contribution to science and medicine. You are probably wondering how this story even makes a little bit of sense. How can someone who has died contribute to progress in medicine without even knowing? Allow me an opportunity to explain the very interesting story of Henrietta Lacks and how she lives on through medical research.
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Medical Devices | Reliability | Use Case | HALT | quality

Reliability – From Bike Racks to Medical Devices

Every once in a while, when I’m not running, I like to take my bike down to the river trails of downtown Pittsburgh. I throw my bike rack on my car, strap it in, and I’m ready to go. Being as I only used my bike rack about ten times since I got it, I was surprised when I went to secure the bike and the plastic strap was broken. The strap is not removable or replaceable, so for now I’ll have to stick to running. Luckily, I have my receipt and the manual that came with the bike rack – and it says there is a lifetime warranty. I wrote a short note to the company explaining my situation and am hoping to get a positive response.
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massage therapy | medical industry | massage | Insurance | therapy

Vacation Revelation

I am in TopSail North Carolina this week enjoying the ocean, sun and family! (Yes: in that order)
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class iia | EU | disease management | mobile platform | mobile medical applications | health management | FDA | Substantial Equivalence | verizon wireless | software platform | medical applications | software technologies | medical application

Mobile Medical Applications - Most Reliable Apps, Internationally?

A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!
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Fear Factor: Audits

Why is it that when you drop the A-bomb (audit) people just seem to instinctively cringe. Is this a learned behavior or one that has been passed down since men began assessing each other for acceptance?
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medical corporation | pittsburgh pa | staying power | fagan | medical device | Pittsburgh Technology Council | quality solutions

Device Idea to Staying Power in the Market

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RQS Ohio Social Event - August 14, 2013

Please join RQS for a happy hour networking event! Drinks and appetizers will be provided and prizes will be given away to winning attendees during the event.
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guidance | CDER

Guidance document clean-up! - CDER

I read an interesting article on the RAPS website this morning about a new initiative set by the FDA to clean-up certain guidance documents. This means finalizing draft guidance documents, withdrawing or updating/revising outdated guidance documents. This initiative is taking place in the Center for Drug Evaluation and Research (CDER) department.
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Draft Guidance on Medical Device Reporting for Manufacturers - Issued 07/09/13

Earlier last month, FDA released a new draft guidance that addresses many questions and answers pertaining to the sometimes tricky world of medical device reporting for medical device manufacturers. (1-4) The draft guidance, “Draft Guidance on Medical Device Reporting for Manufacturers(3),” aims to clarify a wide array of requirements of the MDR. It has been over 15 years since the last MDR draft guidance was published by the FDA.(1-3) Since 1997, industry has seen a variety of “text book” examples of medical device reporting - some good and some bad – and many lessons have been learned.When the draft guidance that was issued on 07/09/13 is final, it will supersede “Medical Device Reporting for Manufacturers” issued in 1997.(3-4)
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nutrition | supplements

Super Supplements or Scary Supplements: Consumers are the Judge

While doing my usual read-through of the headlines on USA Today, I recently came across an article about a USA Today investigation examining the works of Matt Cahill, a supplement designer with a dark history in developing risky products. As an individual who tries to maintain a healthy lifestyle and enjoys working out, the findings of this investigation made me question the supplements I have been using. As most people who do, I take supplements (ie vitamins, protein powder, fish oil) to enhance my diet with nutrients and help me maximize the benefits gained from hitting the gym. However, as I have come to learn from this article we the consumers need to be proactive in determining and choosing supplements that are safe to take.
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standards | iso 14971 | risk management | Standards Compliance

“It’s like getting your high school diploma…”

Recently, I had the opportunity to attend a Risk Management Conference hosted by the FDAnews. At the beginning of the conference, we all went around the room and introduced ourselves, and indicated why we were there. Not surprisingly, a majority of people were there to have a better understanding of the new EN version of ISO 14971 - EN ISO 14971:2012, and learn how to implement it into their daily risk management activities.
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Just Say No

So you think you’re a bargain shopper, huh? Did you secretly get a rush when you had a coupon for that high-end toothpaste AND found it on sale? Most bargain shopping comes with few, if any, downsides. (Ok, so maybe you had to evict a family of angry possums from that couch you picked up in the neighbor’s trash pile, but hey – you can stand a little inconvenience for something free!) But when it comes to your health, how much are you willing to risk for a bargain? In order to off-set rising out-of-pocket healthcare costs, many consumers shop around for cheaper medications, often purchasing counterfeit pharmaceuticals through unregulated channels without even knowing it. These drugs often look exactly like their legitimate counterparts but may contain incorrect doses of the active ingredients or incorrect ingredients altogether.1 Patients looking to save a few bucks could be putting themselves at serious risk, as modified or diluted medications have potential to weaken the immune system and expedite the spread of disease.2 The issue may be more widespread than we realize though…
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FDA Medical Device Reporting Update

One of the ways that I try to stay in touch with the world of medical device regulations is by subscribing to the CDRH (Center for Devices and Radiological Health) mailing lists (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm135906.htm). This service helps keep you abreast of the recalls, safety, device clearances and updates to regulations.
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Ombudsman | CDRH

How the FDA handles complaints

Complaints from end users to medical device manufacturers are unfortunately a common occurrence. Medical device manufacturers are expected to handle these complaints efficiently and effectively by keeping the end user or patient’s safety in mind. However not a lot of people think about how the FDA has to handle complaints from medical device manufacturers.
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biosense | 21 cfr | fda guidance | mobile medical applications | FDA | medical device | submission type | mobile application | medical applications | regulatory strategy | medical application

Mobile Medical Applications: Make Sure uChek with FDA

The latest mobile medical application news on the industry's collective mind is the issuance of an "It has come to our attention..." letter sent to Biosense Technologies in India, essentially questioning why Biosense has not obtained 510(k) clearance for their uChek mobile application. The device is a mobile medical application for phones that takes a picture of urinalysis strips and compares the color against a standard to make a determination about the status of a patients urine. It also includes a box that controls external light to ensure better quality of the results. From a "fan" standpoint, it's an awesome device and technology. You can see it demo-ed during the TED talk given by the company's CEO.
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fundamentals of engineering

Documentation 101: Life as an Engineer