Device Week, 13 August 2021 – TriGUARD 3 FDA Panel Meeting; Experts Talk QS Reg

In this week’s podcast we take a look at the concerns a US FDA advisory panel recently expressed about Keystone Heart’s TriGuard 3, then discuss some expert comments on the FDA’s hotly anticipated Quality System Regulation rewrite.

 

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The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Podcasts and via smart speakers if one of these platforms has been set up as your default podcast provider. 

Medtech Insight articles addressing topics discussed in this episode:

• TriGUARD 3 Data Does Not Pass Muster: FDA Experts
• QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo