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Listen "CE Certification vs FDA Submission Strategy: Which is Right for You?"
Episode Synopsis
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.
Michelle leads off with a review of FDA strategies and pathways.
15:34 - Ronald dives into the particulars of MDR and dealing with notified bodies.
27:15 - Nika Mendelev explains whether you really need to choose one or the other.
32:10 - the Q+A session begins.
Link to the full presentation on YouTube: https://youtu.be/4wyZzVibiAY
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.
Michelle leads off with a review of FDA strategies and pathways.
15:34 - Ronald dives into the particulars of MDR and dealing with notified bodies.
27:15 - Nika Mendelev explains whether you really need to choose one or the other.
32:10 - the Q+A session begins.
Link to the full presentation on YouTube: https://youtu.be/4wyZzVibiAY
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