LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career
Let's Talk Risk! Podcast
- Published
- December 19, 2025
- Duration
- 31:44
- Summary source
- description
- Last updated
- Apr 29, 2026
Discusses Summary“FDA isn’t asking whether you followed the procedure. They are asking whether your system can…
Summary
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-ba…
Show notes
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 c