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ASCA, CLAP, Fraudulent Biocompatibility Data and You

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Manage episode 441605611 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.
Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Some unethical third-party testing labs are sending their clients data mined from old 510(k) submissions - and passing it off as fresh data. So what's a medical device manufacturer to do? That was the topic of conversation this month when I chatted with Mike McGrew and Sandi Schaible from WuXi AppTech. LinkedIn: https://www.linkedin.com/in/michellelottraqa Website: https://leanraqa.com/ YouTube: https://www.youtube.com/@leanRAQA Instagram: https://www.instagram.com/leanraqa
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51 episodes

Artwork
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Manage episode 441605611 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.
Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Some unethical third-party testing labs are sending their clients data mined from old 510(k) submissions - and passing it off as fresh data. So what's a medical device manufacturer to do? That was the topic of conversation this month when I chatted with Mike McGrew and Sandi Schaible from WuXi AppTech. LinkedIn: https://www.linkedin.com/in/michellelottraqa Website: https://leanraqa.com/ YouTube: https://www.youtube.com/@leanRAQA Instagram: https://www.instagram.com/leanraqa
  continue reading

51 episodes

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