This session will contain critical information for any decision-makers doing business in the UK or Europe in the continually turbulent post-Brexit world.Duration: 26:13
Will what I have be enough or am I planning for too much? How do I get the functions aligned... PMS, regulatory, risk, clinical, and marketing? Our panel answers these questions and more.Duration: 32:43
The requirements in the regulation are new and seem to overlap with existing reports. We have yet to see any specific guidance or the PSUR template rumored to be in development and if SSCP and PMCF are any indication, it will be extensive. Where does that leave the industry on how far to go with data and analysis in the initial PSUR, what will be good enough to satisfy the notified bodies? Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies.Duration: 39:34
Our panel discusses strategies and best practices for developing PEP's and PERs.Duration: 40:02
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
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