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Ventilators, Components and Accessories - Choosing the Right FDA Pathway for Your Product
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Manage episode 284029285 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.
Have you ever struggled to understand the regulatory difference between a product, an accessory and a component? Have you ever driven yourself slightly mad trying to determine the best FDA submission pathway for that product, accessory or component? A group of medical device manufacturers asked those very same questions during a presentation I gave in the fall of 2020. The answers apply to more than just ventilators, so there is something in this video for just about everyone. If you want to view the video version with the slide deck, check it out on my YouTube channel: https://youtu.be/e-UTXSFwHaw Enjoy!
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44 episodes
MP3•Episode home
Manage episode 284029285 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.
Have you ever struggled to understand the regulatory difference between a product, an accessory and a component? Have you ever driven yourself slightly mad trying to determine the best FDA submission pathway for that product, accessory or component? A group of medical device manufacturers asked those very same questions during a presentation I gave in the fall of 2020. The answers apply to more than just ventilators, so there is something in this video for just about everyone. If you want to view the video version with the slide deck, check it out on my YouTube channel: https://youtu.be/e-UTXSFwHaw Enjoy!
…
continue reading
44 episodes
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