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LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
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 differently - embedding risk management early, strengthening design controls, and elevating…
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