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Medtech Matters · Apr 17, 2026

Triaging Your QMS: Considerations Based on the New QMSR

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing the FDA’s recently implemented QMSR. It went into effect on February 2nd and replaced 21 CFR Part 820. The regulation incorporates ISO 13485:2016, which is expected to help align medical device regulations globally. In this podcast, we focus on what device manufacturers…

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