Note: A version of this post was initially published for the flagship online publication of RAPS, Regulatory Focus™
In an effort to further support the medical device industry during the COVID-19 pandemic, we've been spreading love more than ever in one of the best ways we know how: free industry-leading education. In April, R&Q debuted a new live show: RQM+ Live!
Webcams in, presentation slides out: The biweekly panel discussions focus on answering questions, engaging in friendly debate, sharing some laughs, and always, always... offering solutions and value.
In hopes that you see a topic that interests you and aligns with your objectives, we've ranked the most popular episodes of the show to this point below. Additionally, these and all shows are also available via our Device Love Podcast.
The top 10.
1. #3 (1 May) — Recent MDD and MDR Audit Findings: What are we seeing?
The most popular episode featured R&Q experts providing recommendations on where to focus your resources to increase the odds of passing a notified body audit without major findings. We know the MDR has brought about increased scrutiny, and this panel is an excellent summary of what we've been seeing.
A close second, this discussion covered best practices and novel approaches for fulfilling the requirements. Demonstrating "sufficient clinical evidence" is now a clear and enforced requirement for applications under the EU MDR. If you don't have adequate clinical data, what can you do... particularly, if you can't claim equivalency? Panelists also share a few creative ideas for generating data during the COVID-19 pandemic.
3. #7 (28 May) — Getting Legacy Device Risk Files Ready for EU MDR / ISO 14971:2019
Under EU MDR, notified bodies are required to look at every technical documentation file at least once in a five-year period. This is particularly troubling for companies with devices marketed 10+ years ago, for which the tech files haven't been reviewed critically since the early years on the market. In this session, the panelists discuss efficient approaches to get files audit ready and expectations of the notified bodies.
4. #14 (30 July) — Is your device a Well-Established Technology (WET) under EU MDR?
The EU MDR didn't provide a definition, but, the MDCG-6 Guidance on sufficient clinical evidence for legacy devices provides one and further details around sufficient clinical evidence for WET and non-WET devices. Even with this guidance, we're still seeing debate between device companies and their notified bodies on what is classified as WET. This panel includes tips on how to interact with your notified body. See a sample on LinkedIn from this episode.
5. #8 (4 June) — FDA Trends: Inspections and Submissions
Trying to balance out all the EU love! This panel features multiple former FDA leaders and is full of lively discussion about whether or not the FDA is going harder or lighter on inspections, the scrutiny 510(k) submissions are facing, and more.
6. #6 (21 May) — PMCF Process in Action: Best Practices for MDR Compliance
The focus of this session is on PMCF questions we're seeing during notified body review and best practices to help manufacturers avoid having them raised in the first place! We talk about best practices for developing a clinical evaluation matrix and our interpretation of the MDCG 2020-6 guidance on sufficient clinical evidence for legacy devices, then using it all to drive an overall PMCF strategy and execution of PMCF plans and reports using MDCG 2020-7 and MDCG 2020-8.
7. #9 (11 June) — Experiences with the FDA 3rd Party 510(k) Review Program
The Program has been in use for many years, having been written into law in 1997. Back in March of 2020, the FDA released the guidance document, "510(k) Third Party Review Program," based on the draft issued in 2018. Under the this Program, referred to as "3P510k" by FDA, 3P510k Review Organizations review a 510(k) submission and then forward their review, the 510(k) submission, and a recommendation (e.g., substantially equivalent (SE) or not substantially equivalent (NSE)) to FDA. FDA reviews the 3P510k Review Organization’s memo and recommendation, and makes a final decision on the submission. This panel discusses their experiences with the Program, the pros and cons, and recommendations on when to use it... and when to avoid it.
8. #5 (14 May) — Chatting with Former FDA and Notified Body Representatives
In this open discussion that resulted in some interesting insights, the panel answers all sorts of questions they couldn't in their previous roles. What's it like moving from government to industry? What do they wish both sides knew about the other? What are key takeaways to successfully navigate the system?
9. #10 (18 June) — Transition to IVDR: How far along should we be?
The transition from MDD to MDR for medical device manufacturers feels relatively small in comparison to the 85% of IVD companies moving from self-certified to notified body audits, complex regulatory systems, and the expectations of much tighter controls over the web of virtual manufacturing and distribution relationships that IVD companies are accustomed to. The clock is ticking and 2022 is not far away. This panel discusses how far along IVD companies should be, good milestones to set this year and next, resources, economic operators, and more.
10. #12 (2 July) — Tips and Tricks for a Smooth 510(k) Process
Whether on your first 510(k) submission at a startup or your 50th at a large company, most RA/QA professionals have at least some anxiety over the unpredictability of the process. This panel is full of submission experts, including recent CDRH staff, who cover most aspects of 510(k) submissions: content, compilation, format, internal review, communication with FDA, Refuse-To-Accept (RTA) issues, fulfilling requests for additional information, and more.
There you have it! To stay updated on RQM+ Live! topics are on the horizon, please subscribe to our Resources blog.