Episode 10: As of February 2, 2026, the FDA has officially begun enforcing the Quality Management System Regulation (QMSR)—marking a major shift in how medical device quality systems are evaluated during inspections.
In Part 1 of this QT9 Q-Cast episode, host Christian Reyes speaks with Michelle Keane, QA/RA Director at ComplyGuru, to clarify what QMSR actually means for manufacturers today. Rather than focusing on implementation tactics, this episode establishes the foundation: why the FDA made the change, what inspectors will now prioritize, and where legacy QSR assumptions fall apart.
QMSR formally aligns FDA regulations with ISO 13485, but Michelle emphasizes that this is not a copy-and-paste adoption of ISO. FDA authority remains intact, and several QSR requirements—such as complaint handling, CAPA, medical device reporting, traceability, labeling, and UDI—are explicitly retained. These areas continue to be the strongest drivers of FDA enforcement.
The discussion also explores the retirement of QSIT and what replaces it. Under QMSR, inspections become risk-based and data-driven, with FDA inspectors following risk signals across interconnected processes rather than auditing procedures in isolation. Documentation still matters—but only in so far as it supports sound decision-making under risk.
Michelle explains why organizations that relied solely on U.S.-only QSR compliance may feel the transition most, and why ISO-certified companies are not automatically QMSR-ready. Risk management is no longer confined to design controls—it now underpins internal audits, management review, CAPA prioritization, and leadership oversight.
A recurring theme in Part 1 is accountability. FDA inspections under QMSR increasingly evaluate whether leadership decisions make sense when risk is present—not whether a checklist was completed. Companies with siloed systems, disconnected data, or performative compliance practices will struggle to demonstrate control.
For quality professionals, regulatory leaders, and executives, this episode provides the context needed to understand how FDA inspections change under QMSR—before tackling execution. The message is clear: QMSR changes the inspection mindset first, and everything else follows.
Michelle Keane
QA/RA Director, ComplyGuru
Lead Auditor & MDR Assessor
Links & Resources
Referenced Standards & Regulations