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: CE marking, ce marking medical devices, how will the mdr affect ce markings, how will the new mdr affect my qms, medical device regulation, medical devices, eu mdr, mdr, conformity assessment, ce marking certification, ce marking process, ce marking technical file, 501k submissions, fda submissions, 510(k) submissions, fda pre submission, medical device submissions, fda medical device submissions, fda pre-submission, leanRAQA, Michelle Lott, FDA submission strategy