Under EU MDR, notified bodies are required to look at every technical documentation file at least once in a five-year period. This is alarming 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. Our panelists explore efficient approaches to getting these files ready and the expectations of notified bodies.Duration: 39:03
Our panelists focus on PMCF questions we are seeing during notified body review and best practices to help you avoid having these questions raised in the first place! We describe 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 to drive an overall PMCF Strategy and execution of PMCF Plans and Reports using MDCG 2020-7 and MDCG 2020-8.Duration: 46:32
What's it like moving from government to industry? What do they wish both sides knew about the other? Our former FDA and notified body representatives answer these interesting questions and more.Duration: 39:43
RQM+ experts talk about what we are seeing across the medical device industry and provide recommendations on where to focus your resources to increase the odds of passing a notified body audit without major findings.Duration: 39:53
This show addresses both emergency applications and covers the over process and requirements, what products the regulatory routes can be used for, what the processes are not intended for, and more.Duration: 29:48
Device manufactures have a good handle on how to relocate manufacturing into China; we’ve all been on at least one of those projects in our careers. But how do we move it back out? What are the obstacles and strategies for success?Duration: 36:01
Our panelists have created a significant amount of MDD and MDR technical documentation files. Listen to hear their strategies!Duration: 55:02
Learn from RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day.Duration: 51:40
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