FDA submission experts, including recent CDRH staff, discuss when to use the pre-sub process, real and perceived risks associated with the process, tips and tricks to achieving a successful meeting, and case studies of our experiences.Duration: 32:33
In this show, we provide our current thinking on the WET debate and some tips for interacting with your notified body.Duration: 32:41
Our panel discusses elements of software and intended use that trigger medical device requirements, the process for making a determination, tips on steering clear of a device classification, and examples on both sides.Duration: 25:03
Whether you're on your first 510(k) submission at a startup or your 50th at a large company, you likely have some anxiety over the unpredictability of the process. The panel includes recent CDRH staff who will discuss their tips and tricks for a smooth 510(k) submission process.Duration: 44:34
This panel discusses best practices and novel approaches to fulfilling sufficient clinical evidence requirements, supported by those that have been accepted by notified bodies in audits.Duration: 43:27
How far along should IVD companies be in the transition process? With limited resources, where should you focus? Our panel discusses these questions and more.Duration: 34:28
This panel features our experiences with the 3P510k program, the procs and cons, and recommendations on when to use it and when to avoid it.Duration: 23:56
What's the latest in FDA trends? Is the FDA going harder or lighter on inspections? Our panelists tackle these questions and more.Duration: 31:57
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
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