LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR

from Let's Talk Risk! with Dr. Naveen Agarwal · host Where MedTech professionals gain clarity and confidence to navigate complex decisions.

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Don’t wait. You need time not just to update your procedures, but to generate the records FDA will expect to see the day they walk through your door.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal and Michelle Lott from Lean RAQA discuss the upcoming Quality Management System Regulation (QMSR) for medical devices, emphasizi…

Episode metadata supplied by the publisher feed · Published Aug 29, 2025

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LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR

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