LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career

Let's Talk Risk! Podcast · Dec 19, 2025 · 31m

Summary

“FDA isn’t asking whether you followed the procedure. They are asking whether your system can assure consistent outcomes in the real world.”

In this episode of the Let's Talk Risk Podcast, Priya Setty joins host Naveen Agarwal to unpack why QMSR represents more than a procedural update; it’s a mindset shift toward assurance, credibility, and risk-based decision making across the entire product lifecycle. Priya shares how the FDA’s alignment with ISO 13485 elevates expectations for design controls, risk integration, software assurance, and role-specific competence.

Drawing on her…