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

Executive Summary

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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Medtech Insight articles addressing topics discussed in this episode:

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