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CE Certification vs FDA Submission Strategy: Which is Right for You?

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Manage episode 443001723 series 2446473
Content provided by RAQA Today and Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RAQA Today and Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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
  continue reading

51 episodes

Artwork
iconShare
 
Manage episode 443001723 series 2446473
Content provided by RAQA Today and Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RAQA Today and Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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
  continue reading

51 episodes

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