Episode
LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
- Podcast
- Let's Talk Risk! Podcast
- Published
- Nov 21, 2025
- Duration seconds
- 1722
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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 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 competence beyond routine training. Drawing from her diverse experience across AI-enabled SaMD, diagnostics, and implantables, Megan shares how agile organizations can turn regulatory change into an advantage. She discusses building risk-based quality systems, tapping external expertise through fractional leadership, and fostering a culture of continuous learning where expertise grows with every project. Chapters 00:00 Why QMSR matters now 02:00 Inside the startup mindset: energy, agility, and chaos 04:30 From checklists to connected processes 06:45 How FDA’s expectations are evolving 09:50 Integrating risk management with design controls 13:30 Competence vs. training: what QMSR really demands 15:30 Startups and global thinking: harmonization as opportunity 18:00 Leveraging networks and external expertise 22:00 Building courage and translating skills to new domains 24:00 Overcoming imposter syndrome and redefining expertise 26:30 Final takeaways and Megan’s vision for Relia Suggested links: * LTR: A 90-day plan to review QMSR readiness . * LTR: Risk, CAPA and FDA inspections under QMSR . * LTR: QMSR QuickTake #1: From compliance to assurance . Key Takeaways * The QMSR transition signals a…