Smart Quality Planning
Let's Talk Risk! Podcast
LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
- Published
- February 27, 2026
- Duration
- 28:21
- Summary source
- description
- Last updated
- Apr 29, 2026
Discusses Summary“You don’t want to be implementing QMSR while the FDA is waiting in the lobby.”As the FDA tra…
Summary
Summary“You don’t want to be implementing QMSR while the FDA is waiting in the lobby.”As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion persists across the MedTech industry. Is ISO 13485 certification enough? Does MDSAP cover everything? What exactly will FDA inspectors expect…
Show notes
Summary“You don’t want to be implementing QMSR while the FDA is waiting in the lobby.”As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion persists across the MedTech industry. Is ISO 13485 certification enough? Does MDSAP cover everything? What exactly will FDA inspectors expect?In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits down with Holly Cotter to talk about what this transition really mean