LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
Let's Talk Risk! Podcast
- Published
- November 21, 2025
- Duration
- 28:42
- Summary source
- description
- Last updated
- Apr 29, 2026
Discusses Summary“If you’re a small company and feel stuck in the QMSR transition, use that startup energy. Ge…
Summary
Summary“If you’re a small company and feel stuck in the QMSR transition, use that startup energy. Get creative, tap your network, and find the experts who can help you get unstuck.”In this episode of the Let's Talk Risk Podcast, Megan Kane joins host Dr. Naveen Agarwal to unpack what the FDA’s new Quality Management System Regulation (QMSR) means for star…
Show notes
Summary“If you’re a small company and feel stuck in the QMSR transition, use that startup energy. Get creative, tap your network, and find the experts who can help you get unstuck.”In this episode of the Let's Talk Risk Podcast, Megan Kane joins host Dr. Naveen Agarwal to unpack what the FDA’s new Quality Management System Regulation (QMSR) means for startups and small MedTech companies. She explains how the shift from checklist compliance to process-based assurance challenges teams to think dif