RQM+ Medical Device and In Vitro Diagnostic Blog

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 26 August 2019 | By Stephen Biernacki

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 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 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 16 January 2019 | By Nancy Morrison, RQM+

Hope for the best, but prepare for the worst.

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 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 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 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 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 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 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 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 4 December 2012 | By Ryan Kasun

Yesterday, the United States Court of Appeals for the Second Circuit (based in NYC) made a 2-to-1 decision on United States v. Caronia (just one of many criminal cases pertaining to off-label use). This case even contained a supplemental briefing that had the litigants brief the...