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MDR, FDA and Other Regulatory Realities

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Manage episode 341946111 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://player.fm/legal.
When submitting a medical device for regulatory approval, it's always better to just dive in, accepting the fact that it's going to take a lot of work and require a lot of patience before you feel the glow of market clearance or approval. There are just SO MANY things to consider, and remember, and document, and SO MANY regulations to refer to on both sides of the Atlantic. In this edited version of a Greenlight Guru podcast from earlier this year, I discuss the roadblocks that exist on both sides of the Atlantic with Jon Speer and Etienne Nichols - and share what you can do to make sure you don't end up with an MDR or FDA-induced hangover.
  continue reading

44 episodes

Artwork
iconShare
 
Manage episode 341946111 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://player.fm/legal.
When submitting a medical device for regulatory approval, it's always better to just dive in, accepting the fact that it's going to take a lot of work and require a lot of patience before you feel the glow of market clearance or approval. There are just SO MANY things to consider, and remember, and document, and SO MANY regulations to refer to on both sides of the Atlantic. In this edited version of a Greenlight Guru podcast from earlier this year, I discuss the roadblocks that exist on both sides of the Atlantic with Jon Speer and Etienne Nichols - and share what you can do to make sure you don't end up with an MDR or FDA-induced hangover.
  continue reading

44 episodes

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