RQM+ Medical Device and In Vitro Diagnostic Blog

on 9 December 2024 | By Jaishankar Kutty, Ph.D., RQM+ Vice President, Global Regulatory Affairs

Executive Summary Tricuspid regurgitation (TR), historically overshadowed by left-sided valvular diseases, is increasingly recognized as a significant contributor to heart failure (HF) symptoms, hospitalizations, and mortality. Despite its prevalence, TR often remains...

on 2 December 2024 | By Jaishankar Kutty, Ph.D., RQM+ Vice President, Global Regulatory Affairs

Introduction: The (Not So) Forgotten Tricuspid Valve Tricuspid regurgitation (TR), historically overshadowed by left-sided valvular diseases, is increasingly recognized as a significant contributor to heart failure (HF) symptoms, hospitalizations, and mortality. Despite its...

on 26 November 2024 | By Dr Dr Cordula M Stover, Senior Medical Writer, RQM+

A clinical study design describes the methodology with which to pursue the aims and objectives of a clinically important research question in a target population.

on 15 November 2024 | By Jaishankar Kutty, Ph.D., RQM+ Vice President, Global Regulatory Affairs

Heart failure with reduced ejection fraction (HFrEF) is a progressive condition affecting millions worldwide, imposing both a clinical and economic burden on patients and healthcare systems. While guideline-directed medical therapy (GDMT) remains the cornerstone of treatment,...

on 14 November 2024 | By Dr Dr Cordula M Stover, Senior Medical Writer, RQM+

The purpose of clinical studies is to scientifically address an unmet clinical or regulatory need in the treatment of patients. Informing clinical practice and policy, the outcomes ultimately aim to improve health care. Working in a client centric manner, RQM+ helps navigate...

on 30 October 2024 | By Margot Borgel, Ph.D., Director, IVD Global Regulatory Affairs, RQM+

The uncertainty in the future of LDTs cannot be overstated; there are any number of things that can happen over the course of the next months and years, leaving laboratories in a very uncertain environment. The lawsuits against FDA by American Clinical Laboratory Association...

on 21 October 2024 | By Jaishankar Kutty, Ph.D., RQM+ Vice President, Global Regulatory Affairs

As the regulatory landscape for medical devices and in vitro diagnostics (IVDs) in the European Union becomes more stringent, the need for transparent and efficient communication between manufacturers and notified bodies has never been more critical. The structured dialogue...

on 3 October 2024 | By Margot Borgel, Ph.D., Director, IVD Global Regulatory Affairs, RQM+

Point of Care tests (POCT) is a term that is widely used to describe IVDs that are used at the same location as the patient, as opposed to an IVD that is used within a laboratory. This can include a wide range of locations including doctor's offices, clinics, patient bedside,...

on 19 September 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution

Slightly overdue, we wanted to highlight one of many discussion points in relation to proposals for international recognition pathways to access the Great Britain (GB) market. The recent update of the FDA’s data on Artificial Intelligence and Machine Learning (AI/ML)-Enabled...

on 14 August 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Medical devices comprise any number of materials, typically a combination of metal, ceramic, and/or polymers. The exact composition depends primarily on the desired functionality. A tongue depressor, for example, is one of the simplest devices in a medical practitioner’s...

on 4 August 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution

Equity in medical devices is a relatively hot topic, especially for regulators. The World Health Organization (WHO) describes health equity as follows [1]:

on 29 July 2024 | By Margot Borgel, Ph.D., Director, IVD Global Regulatory Affairs, RQM+

FDA released the final rule on laboratory developed tests (LDTs) on May 6, 2024. This rule brings most LDTs under the purview of FDA through the medical device regulation by including them within the definition for in vitro diagnostics (IVDs).

on 24 July 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution

Since their proposal in early 2024, the MedTech industry has been awaiting the formal publication of the latest round of amendments to the EU MDR 2017/745 and IVDR 2017/746. The amendments have now been formally published in the form of Regulation 2024/18601. The regulations...

on 11 July 2024 | By Dr Dr Cordula M Stover, Senior Medical Writer, RQM+

“The world is moving so fast these days that the man who says it can't be done is generally interrupted by someone doing it.” ― Elbert Hubbard

on 8 July 2024 | By Jonathan Gimbel, PhD, RQM+ Vice President, Technical

The EPA published a final rule this year requiring EtO sterilization facilities to significantly reduce EtO emissions. Since EtO sterilization is used for approximately 50% of sterile medical devices (estimated at over 20 billion devices sold in the U.S every year) [1], this...

on 27 June 2024 | By Kaitlin Lerner, Vice President, Lab Services

Chemical characterization is an integral part of the life sciences industry. It factors into all aspects of pharmaceutical and medical device development, from preclinical research and early risk analysis to post-marketing surveillance of end products. The approach varies,...

on 26 June 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Analytical testing is a cornerstone of pharmaceutical development. It is, of course, essential for ensuring the efficacy and safety of drugs released to market. But compliance and process optimization needs go hand-in-hand with product QA/QC. Various test methodologies factor...

on 29 May 2024 | By Scott Edwards, Managing Director, RQM+

Most of us are familiar with the fast-paced world of MedTech and the mounting pressures to maintain product quality, safety, and compliance companies face. With the FDA increasing the number of Class I recalls and the EU MDR/IVDR placing greater responsibilities on the Person...

on 22 May 2024 | By Erin Gontang, Senior Consultant, RQM+

The FDA's recently proposed rule on wound care products has sent ripples through MedTech. This rule, if finalized, could significantly impact the classification, labeling, and testing requirements for a wide range of wound care devices.

on 14 May 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Failure analysis is a critical field used to detect chemical and mechanical defects in polymeric materials, pinpointing the factors that have contributed to or directly resulted in product failure. This analytical discipline plays a pivotal role in enhancing the properties and...

on 23 April 2024 | By Taryn Meade, Jordi Labs/RQM+ Director of Biological Evaluation

We're thrilled to announce a significant development from the FDA’s Center for Devices and Radiological Health (CDRH) that introduces a new regulatory science tool for chemical characterization. This groundbreaking tool is a huge step moving toward improved chemical...

on 11 April 2024 | By Stephen Biernacki, Marketing Principal

In this heartfelt and insightful video presentation, Nancy Morrison – as highly a respected professional as you'll ever find in regulatory affairs – shares her journey and the lessons she's learned along the way. As she embarks on her well-deserved retirement, Nancy generously...

on 2 April 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Regulations in both the EU and US are rapidly changing in order to address the health and environmental risks posed by per- and poly-fluoroalkyl substances (PFAS). Through the EU REACH regulation, it has been proposed to restrict PFAS which will preclude manufacturers from...

on 20 March 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution

We used the publication of the final rule amending the US Quality System Regulations (QSR) as an example in our recent blog titled Enhancing Competitiveness in MedTech: Smart Strategies with Regulatory Intelligence. Here we will look at the final rule, and its implications in a...

on 15 March 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Extractables and leachables are potentially hazardous chemicals that a patient can be exposed to when using medical devices or drug products. These chemicals may be present as impurities in the materials used, but also may be introduced during manufacturing or storage....

on 14 March 2024 | By Richard Freeman, Director, Global Audit Practice

Staying ahead of compliance and regulatory requirements needs to be a top priority for MedTech companies. Audits are an integral part of maintaining these standards, but can often be seen as stressful and time-consuming events. However, the perspective shifts when these are...

on 11 March 2024 | By Niki Spaniel, RAC, Principal, CPMP, Practice Manager and Anastassia Young, MS, Senior Consultant

The FDA Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices program may benefit manufacturers in reducing the burden of medical device reporting (21 CFR Part 803, under 21 CFR 80.309(b) where real world data/evidence is being collected,...

on 29 February 2024 | By Margot Borgel, Director, IVD Global Regulatory Affairs

Team-NB recently released a position paper regarding the classification of devices to detect SARS-CoV-2. These devices are currently cited in the MDCG 2020-16 classification guidance as an example of a device falling under Rule 1, 2nd indent, which states: "Devices intended to...

on 20 February 2024 | By Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence and Innovation and James Wrenn, Director, Solutions Delivery RQM+

The impending phase-out of per- and polyfluoroalkyl substances (PFAS) presents a significant challenge for MedTech companies. After all, PFAS has been an integral component in manufacturing many MedTech devices.

on 12 February 2024 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation

Published in December last year, MDCG 2023-7 clarifies when clinical investigations are not mandatory for Class III and implantable devices. MDCG 2023-7 also shares updated guidelines for when data from equivalent devices may be used in a clinical evaluation under the EU Medical...

on 6 February 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution

What is regulatory intelligence? Ok, so what on earth are we talking about when we say regulatory intelligence? There are no formal definitions for regulatory intelligence in regulations or standards relating to medical devices or in vitro diagnostic devices. Without delving...

on 3 January 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

While biocompatibility testing is necessary to develop safe MedTech devices, several issues complicate the process. From the initial study setup to deriving accurate conclusions, complications can arise at each testing stage. That’s bad news. Any testing obstacles can delay...

on 21 December 2023 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation

Introduction to the New MDCG Guidance A new MDCG guidance document has been published today, providing welcome clarification regarding the practical application of EU MDR Articles 61(4) – (6). This new guidance, "MDCG 2023-7: Guidance on exemptions from the requirement to...

on 12 December 2023 | By Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence and Innovation and James Wrenn, Director, Solutions Delivery RQM+

Major per- and polyfluoroalkyl substances (PFAS) suppliers are beginning to exit the market due to significant environmental, health, regulatory, and legal concerns. That’s mostly a good thing! While PFAS are used in an incredible array of consumer products, including medical...

on 5 December 2023 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

In the MedTech sector, the biocompatibility of materials is critical for patient safety and product efficacy. Every material needs to be tested, with suppliers often providing quality and biocompatibility assurances.

on 16 November 2023 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution

Introduction We have previously talked about the upcoming 2024 EU deadlines for QMS compliance and notified body applications for the EU MDR 2017/745 (5 Essential Tips for EU MDR Compliance and How to Meet the EU's 2024 MDR Deadlines), but what is needed beyond that? What if you...

on 10 November 2023 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

For any MedTech company, the goal of developing products that are both effective and safe is at the heart of their mission. But as these companies build their products, they inevitably encounter testing challenges. Comprehensive testing, while crucial, often comes with a hefty...

on 1 October 2023 | By Eric Pauls, Chief Customer Officer

From navigating the complex regulatory environment to implementing the right quality controls — MedTech companies face many challenges in getting their products to market. These challenges lengthen product development cycles and increase the time it takes to get vital...

on 23 August 2023 | By Margot Borgel, Ph.D., Director, IVD Global Regulatory Affairs, RQM+

Introduction The pathway to IVDR certification for companion diagnostics (CDx) can be overwhelming due to the complexity of the certification process. Certification from a notified body was not previously required, as they were self-certified under IVDD. In addition,...

on 17 July 2023 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution

Introduction Regulation 2023/607 removed the May 2024 transition deadline for medical devices transitioning from MDD/AIMDD to MDR 2017/745. The end of the transition period was pushed back to 2026, 2027 or 2028, depending on the classification of the device.

on 5 July 2023 | By Daniel Lace, MD, Chief Medical Officer

This blog post explores the CMS and AHRQ's proposed TCET pathway, which aims to improve beneficiary access, reduce coverage uncertainty, encourage evidence development and coordinate benefit categories for emerging technologies. It also discusses eligibility criteria for...

on 9 March 2023 | By Ryan Kasun

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...

on 21 November 2022 | By Andrew Tarnaris, M.D. MD (Res) FRCS (NeuroSurg), RQM+ Medical Director

A new opinion (CECP-2022-000222) provided under the Clinical Evaluation Consultation Procedure (CECP) was recently published by the European Commission. Here are some things worth noting, a summary to digest and lessons learnt both for manufacturers and notified bodies alike.

on 21 June 2021 | By RQM+ Subject Matter Experts

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...

on 21 June 2021 | By Celeste Maksim, PhD, RAC, RQM+

on 10 June 2021 | By Kim Platt

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...

on 1 June 2021 | By RQM+ Subject Matter Experts

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...

on 27 May 2021 | By Stephanie Martinez

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....

on 26 May 2021 | By Nancy Morrison, RQM+

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...

on 20 May 2021 | By Nancy Morrison, RQM+

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...

on 18 May 2021 | By Nancy Morrison, RQM+

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.

on 5 May 2021 | By Deven Hennon, RQM+

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.

on 28 April 2021 | By Rem Siekmann, RQM+

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...

on 28 April 2021 | By Rem Siekmann, RQM+

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...

on 28 April 2021 | By Chad Quistad, RQM+

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....

on 28 April 2021 | By Celeste Maksim, PhD, RAC, RQM+

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...

on 28 April 2021 | By Melissa DeHass, RQM+

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...

on 28 April 2021 | By Nancy Morrison, RQM+

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.

on 28 April 2021 | By Nancy Morrison, RQM+

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....

on 8 April 2021 | By Stephen Biernacki

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...

on 17 February 2021 | By Stephen Biernacki

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.

on 16 February 2021 | By Ashley (Ash) Clark, MS, RAC, RQM+

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...

on 1 February 2021 | By Deven Hennon, RQM+

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

on 21 January 2021 | By Kevin Go, MBA, RAC, CQA, RQM+ Senior Principal

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

on 18 January 2021 | By Stephen Biernacki

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

on 11 January 2021 | By Deven Hennon, R&Q

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

on 15 December 2020 | By RQM+ Subject Matter Experts

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

on 7 December 2020 | By Deven Hennon, R&Q

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...

on 1 December 2020 | By Deven Hennon, R&Q

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

on 23 November 2020 | By RQM+ Subject Matter Experts

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.

on 18 November 2020 | By Lisa Casavant, RQM+ EVP

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

on 10 November 2020 | By Celeste Maksim, PhD, RAC, RQM+

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.

on 28 October 2020 | By Deven Hennon, R&Q

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.

on 21 October 2020 | By Nancy Morrison, RQM+

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.

on 16 October 2020 | By Stephen Biernacki

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.

on 14 October 2020 | By Deven Hennon, R&Q

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

on 7 October 2020 | By Deven Hennon, R&Q

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

on 1 October 2020 | By Deven Hennon, R&Q

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.

on 10 September 2020 | By Deven Hennon, R&Q

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 ourRAPS Convergence 2020 announcement page for more information.

on 8 September 2020 | By Stephen Biernacki

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...

on 3 September 2020 | By Deven Hennon, R&Q

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

on 30 August 2020 | By Stephen Biernacki

RQM+ 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...

on 24 August 2020 | By Stephen Biernacki

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...

on 11 August 2020 | By Deven Hennon, R&Q

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.

on 3 August 2020 | By Stephen Biernacki

In our August 2020 webinar you'll learn about the EU MDR and IVDR requirements for economic operators.

on 29 July 2020 | By Deven Hennon, R&Q

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...

on 15 July 2020 | By Deven Hennon, R&Q

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

on 14 July 2020 | By Stephen Biernacki

on 7 July 2020 | By Stephen Biernacki

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

on 6 July 2020 | By Deven Hennon, R&Q

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...

on 29 June 2020 | By Susan Farabaugh, RQM+ Consultant

on 22 June 2020 | By Susan Farabaugh, RQM+ Consultant

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...

on 15 June 2020 | By Deven Hennon, R&Q

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:...

on 9 June 2020 | By Stephen Biernacki

A definitive guide for entering the US market.

on 8 June 2020 | By Deven Hennon, R&Q

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...

on 18 May 2020 | By Deven Hennon, R&Q

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...

on 13 May 2020 | By Deven Hennon, R&Q

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

on 8 May 2020 | By Stephen Biernacki

On-Demand - A webinar entirely dedicated to case studies.

on 8 May 2020 | By RQM+ Subject Matter Experts

Welcome to the Remediation Station! We've got live shows with the experts, case studies, and insights to help you get through remediation successfully.

on 1 May 2020 | By Stephen Biernacki

Chatting with Former FDA and Notified Body Representatives

on 1 May 2020 | By Deven Snyder

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...

on 28 April 2020 | By Deven Snyder

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...

on 27 April 2020 | By Stephen Biernacki

26 May 2020 - Processes, tips, and lessons learned.

on 17 April 2020 | By Deven Snyder

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.

on 15 April 2020 | By Deven Snyder

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...

on 13 April 2020 | By Deven Snyder

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...

on 9 April 2020 | By Stephen Biernacki

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...

on 6 April 2020 | By Stephen Biernacki

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...

on 3 April 2020 | By Stephen Biernacki

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...

on 1 April 2020 | By Stephen Biernacki

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.

on 24 March 2020 | By Deven Snyder

on 19 March 2020 | By Deven Snyder

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...

on 18 March 2020 | By Deven Snyder

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...

on 5 March 2020 | By Stephen Biernacki

Preparing, managing and responding to nonconformances.

on 28 February 2020 | By Stephen Biernacki

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...

on 24 February 2020 | By Deven Snyder

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...

on 31 January 2020 | By Stephen Biernacki

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

on 31 January 2020 | By Deven Snyder

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,...

on 30 January 2020 | By Deven Snyder

March 12, 2020 — Minneapolis, MN

on 30 January 2020 | By Deven Snyder

March 10, 2020 — Boston, MA

on 8 January 2020 | By Stephen Biernacki

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

on 6 January 2020 | By Deven Snyder

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...

on 18 December 2019 | By Deven Snyder

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...

on 27 November 2019 | By Nancy Morrison, RQM+

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...

on 26 November 2019 | By Deven Snyder

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...

on 25 November 2019 | By Stephen Biernacki

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...

on 7 November 2019 | By Deven Snyder

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...

on 5 November 2019 | By Deven Snyder

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...

on 23 October 2019 | By Deven Snyder

November 21, 2019 — Alpharetta, GA

on 8 October 2019 | By Stephen Biernacki

October 29-30, 2019 — Bethesda, MD

on 7 October 2019 | By Stephen Biernacki

October 24-25, 2019 — Bethesda, MD

on 4 October 2019 | By Nancy Morrison, RQM+

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...

on 17 September 2019 | By Stephen Biernacki

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

on 17 September 2019 | By Stephen Biernacki

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

on 17 September 2019 | By Stephen Biernacki

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

on 26 August 2019 | By Stephen Biernacki

on 13 August 2019 | By Stephen Biernacki

September 23-25, 2019 — Boston, MA

on 7 August 2019 | By Stephen Biernacki

August 22, 2019 — Akron, OH

on 1 August 2019 | By Stephen Biernacki

September 9-10, 2019 — Minneapolis, MN

on 27 June 2019 | By Stephen Biernacki

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...

on 26 June 2019 | By Stephen Biernacki

September 21-24, 2019 — Philadelphia, PA

on 21 June 2019 | By Stephen Biernacki

Case studies and tips for EU MDR compliant CERS.

on 18 June 2019 | By Nancy Morrison, RQM+

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...

on 13 May 2019 | By Stephen Biernacki

Data inputs, outputs, and everything in between.

on 9 April 2019 | By Stephen Biernacki

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,...

on 8 April 2019 | By Stephen Biernacki

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...

on 25 March 2019 | By Stephen Biernacki

More companies will require notified body involvement.

on 6 March 2019 | By Stephen Biernacki

EU MDR and the changing regulatory landscape.

on 27 February 2019 | By Stephen Biernacki

March 14, 2019 — Minneapolis, MN

on 27 February 2019 | By Stephen Biernacki

March 19, 2019 — Newton, MA

on 25 February 2019 | By Stephen Biernacki

A notified body perspective.

on 25 February 2019 | By Stephen Biernacki

Answers to the most popular questions we receive.

on 25 February 2019 | By Stephen Biernacki

Are they ready for EU MDR? Are you?

on 25 February 2019 | By Stephen Biernacki

A guide to EU MDR for small companies.

on 25 February 2019 | By Stephen Biernacki

Clinical background on the new requirements.

on 25 February 2019 | By Stephen Biernacki

The requirements and staff it takes.

on 25 February 2019 | By Stephen Biernacki

Know the essential EU MDR portfolio planning requirements.

on 25 February 2019 | By Stephen Biernacki

Gathering clinical evidence.

on 25 February 2019 | By Stephen Biernacki

Does your quality system meet the additional requirements?

on 25 February 2019 | By Stephen Biernacki

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

on 1 February 2019 | By Stephen Biernacki

April 24 — Minneapolis, MN

on 1 February 2019 | By Stephen Biernacki

September 21-24 — Philadelphia, PA

on 1 February 2019 | By Stephen Biernacki

September 23-25 — Boston, MA

on 25 January 2019 | By Stephen Biernacki

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

on 16 January 2019 | By Nancy Morrison, RQM+

Hope for the best, but prepare for the worst.

on 14 November 2018 | By Stephen Biernacki

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...

on 11 September 2018 | By Stephen Biernacki

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...

on 24 July 2018 | By Victoria Chester Rose, Vice President, Marketing & Communications

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...

on 20 July 2018 | By Stephen Biernacki

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...

on 10 May 2018 | By Stephen Biernacki

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,...

on 7 May 2018 | By Stephen Biernacki

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...

on 20 April 2018 | By Stephen Biernacki

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...

on 6 March 2018 | By Victoria Chester Rose, Vice President, Marketing & Communications

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 R&Q influences the medical device industry...

on 8 January 2018 | By Stephen Biernacki

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...

on 14 November 2017 | By Stephen Biernacki

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...

on 13 November 2017 | By Stephen Biernacki

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...

on 24 October 2017 | By Stephen Biernacki

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...

on 2 October 2017 | By Stephen Biernacki

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...

on 19 September 2017 | By Stephen Biernacki

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...

on 12 September 2017 | By Stephen Biernacki

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...

on 21 August 2017 | By Stephen Biernacki

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...

on 8 August 2017 | By Marilyn Waxberg

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...

on 4 August 2017 | By Jake O'Donnell

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...

on 1 August 2017 | By Stephen Biernacki

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...

on 27 July 2017 | By Stephen Biernacki

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...

on 24 July 2017 | By Stephen Biernacki

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...

on 14 July 2017 | By Jyothsna Nunna

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...

on 6 July 2017 | By Stephen Biernacki

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.

on 8 May 2017 | By Nancy Morrison, RQM+

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...

on 2 May 2017 | By Stephen Biernacki

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...

on 18 April 2017 | By Ruthanne Vendy

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...

on 5 April 2017 | By Stephen Biernacki

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...

on 14 March 2017 | By Jake O'Donnell

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...

on 7 March 2017 | By Stephen Biernacki

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...

on 6 March 2017 | By Jake O'Donnell

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...

on 1 March 2017 | By Jake O'Donnell

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...

on 12 February 2017 | By Stephen Biernacki

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...

on 25 January 2017 | By Stephen Biernacki

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...

on 20 January 2017 | By Victoria Chester Rose, Vice President, Marketing & Communications

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...

on 9 January 2017 | By Stephen Biernacki

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...

on 19 December 2016 | By Kate Keverline

♫ 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...

on 16 December 2016 | By Stephen Biernacki

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...

on 13 December 2016 | By Stephen Biernacki

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?...

on 7 November 2016 | By Stephen Biernacki

“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...

on 28 October 2016 | By Stephen Biernacki

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.

on 19 October 2016 | By Stephen Biernacki

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...

on 14 October 2016 | By Kate Keverline

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...

on 7 October 2016 | By Stephen Biernacki

Missed our CAPA on CAPA webinar with MassMEDIC? Now you can download the slides and view the recording.

on 5 October 2016 | By Kate Keverline

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...

on 28 September 2016 | By Stephen Biernacki

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...

on 23 September 2016 | By Victoria Chester Rose, Vice President, Marketing & Communications

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...

on 21 September 2016 | By Stephen Biernacki

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...

on 12 September 2016 | By Stephen Biernacki

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?...

on 8 September 2016 | By Stephen Biernacki

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...

on 7 September 2016 | By Carol Vierling

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...

on 1 September 2016 | By Stephen Biernacki

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...

on 30 August 2016 | By Michelle Mahoney

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,...

on 24 August 2016 | By Nancy Morrison, RQM+

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...

on 16 August 2016 | By Stephen Biernacki

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...

on 3 August 2016 | By Stephen Biernacki

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...

on 12 July 2016 | By Stephen Biernacki

■ ■ ■ 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,...

on 8 July 2016 | By Kate Keverline

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...

on 7 July 2016 | By Stephen Biernacki

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...

on 22 June 2016 | By Stephen Biernacki

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...

on 21 June 2016 | By Stephen Biernacki

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...

on 17 June 2016 | By Kate Keverline

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...

on 13 June 2016 | By Carol Vierling

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...

on 8 June 2016 | By Kate Keverline

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...

on 25 May 2016 | By Kate Keverline

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...

on 24 May 2016 | By Stephen Biernacki

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...

on 20 May 2016 | By Stephen Biernacki

If you have any UDI needs or questions, do not miss this post.

on 17 May 2016 | By Kate Keverline

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...

on 11 May 2016 | By Stephen Biernacki

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...

on 11 May 2016 | By Stephen Biernacki

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...

on 4 May 2016 | By Kate Keverline

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...

on 28 April 2016 | By Stephen Biernacki

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...

on 25 April 2016 | By Kate Keverline

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...

on 15 April 2016 | By Stephen Biernacki

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...

on 13 April 2016 | By Stephen Biernacki

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...

on 23 March 2016 | By Stephen Biernacki

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...

on 8 March 2016 | By Stephen Biernacki

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 18 February 2016 | By Stephen Biernacki

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...

on 15 February 2016 | By Stephen Biernacki

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...

on 12 February 2016 | By Stephen Biernacki

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...

on 8 February 2016 | By Stephen Biernacki

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...

on 2 February 2016 | By Stephen Biernacki

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...

on 26 January 2016 | By Stephen Biernacki

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...

on 22 January 2016 | By Stephen Biernacki

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...

on 14 January 2016 | By Stephen Biernacki

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...

on 6 January 2016 | By Stephen Biernacki

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.

on 1 December 2015 | By Stephen Biernacki

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...

on 13 November 2015 | By Stephen Biernacki

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...

on 2 June 2014 | By Ryan Kasun

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...

on 19 May 2014 | By Ryan Kasun

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...

on 5 May 2014 | By Ryan Kasun

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...

on 21 April 2014 | By Ryan Kasun

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...

on 7 April 2014 | By Ryan Kasun

Healthy CAPAs = Competitive Advantage

on 24 March 2014 | By Ryan Kasun

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...

on 10 March 2014 | By Ryan Kasun

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...

on 21 February 2014 | By Ryan Kasun

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...

on 13 February 2014 | By Ryan Kasun

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.

on 30 January 2014 | By Ryan Kasun

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:

on 22 January 2014 | By Ryan Kasun

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...

on 10 January 2014 | By Ryan Kasun

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!

on 9 January 2014 | By Ryan Kasun

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...

on 9 January 2014 | By Ryan Kasun

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...

on 2 January 2014 | By Ryan Kasun

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

on 20 December 2013 | By Ryan Kasun

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...

on 12 December 2013 | By Ryan Kasun

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...

on 6 December 2013 | By Ryan Kasun

Not So Vulcan Mind Melds

on 2 December 2013 | By Ryan Kasun

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...

on 14 November 2013 | By Ryan Kasun

The Cyborgs Are Coming!

on 14 November 2013 | By Ryan Kasun

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...

on 7 November 2013 | By Ryan Kasun

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?

on 6 November 2013 | By Ryan Kasun

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...

on 31 October 2013 | By Ryan Kasun

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,...

on 24 October 2013 | By Ryan Kasun

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...

on 24 October 2013 | By Ryan Kasun

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...

on 18 October 2013 | By Ryan Kasun

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....

on 18 October 2013 | By Ryan Kasun

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...

on 15 October 2013 | By Ryan Kasun

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,...

on 11 October 2013 | By Ryan Kasun

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....

on 11 October 2013 | By Ryan Kasun

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.

on 11 October 2013 | By Ryan Kasun

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...

on 11 October 2013 | By Ryan Kasun

on 2 October 2013 | By Ryan Kasun

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...

on 1 October 2013 | By Ryan Kasun

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...

on 30 September 2013 | By Ryan Kasun

Good morning!

on 27 September 2013 | By Ryan Kasun

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...

on 25 September 2013 | By Ryan Kasun

on 25 September 2013 | By Ryan Kasun

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

on 19 September 2013 | By Ryan Kasun

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...