Handling audits around the QSR to QMSR transition

Date: May 28th, 2026
Time: 1 PM - 2 PM ET
Presenter: Molly Layne, Audit Manager, Rook Quality Systems

The FDA's Quality Management System Regulation (QMSR) officially replaced the Quality System Regulation (QSR) in February 2026, aligning U.S. device requirements with ISO 13485:2016. For most manufacturers, the rule change is understood. What's less clear is how auditors are applying the new standard in practice, and where the gaps between a QSR-era quality system and QMSR compliance actually show up under scrutiny.

This webinar focuses on the audit side of the transition. Molly Layne brings hands-on experience conducting audits across medical device quality systems. In this session, she'll walk through how audits are evolving under QMSR, where legacy QSR documentation tends to fall short, and what a well-prepared manufacturer should have in place before an auditor walks in the door.

Whether you're preparing for an upcoming audit, mid-transition, or trying to assess where your current system stands, this session will give you a grounded, practical framework for navigating the change.

You will learn:

• How QMSR audit expectations differ from QSR in practice
• The most common gaps auditors are finding in QSR-era quality systems
• How to assess your current system's readiness for a QMSR audit
• Practical steps to close documentation and process gaps before your next audit