Full Video: CE Certification vs FDA Strategy Master Class

Which market is best for your product - the EU or the US?

The answer is not always straightforward, but Ronald Boumans, Nika Mendelev and I did our level best to answer your questions in this Master Class presentation.

Listen to the whole thing or just the parts that interest you:

Michelle leads off with a review of FDA strategies and pathways.
21:12 - Ronald dives into the particulars of MDR and dealing with notified bodies.
35:55 - Nika Mendelev explains whether you really need to choose one or the other.
44:40 - the Q+A session begins.



Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501 medical device regulation, FDA 510(k), medical device classification, FDA 510k clearance, regulatory affairs, FDA 510k approvals, regulatory affairs medical devices, FDA pre submission, regulatory compliance, FDA submission, FDA 510k submission guidance