FDA QSR to QMSR: Regulatory, Legal, and Risk Implications for Industry

Presented by Denise Holliday, MS, RAC-DEVICE, ASQ CQE, CQA - Capwell Consulting

The FDA’s transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) represents a fundamental shift in how medical device quality systems are regulated, inspected, and evaluated. This session provides a practical review of the new requirements, examines the most common FDA Form 483 observations issued since QMSR became effective on February 2, 2026, and explores how these findings may impact manufacturers, product liability litigation, and insurance risk assessments. Attendees will gain insight into emerging compliance expectations, inspection trends, and strategies for reducing regulatory, legal, and financial exposure.

Attendees will learn:

• Key differences between the legacy QSR and QMSR, including FDA’s incorporation of ISO 13485:2016 and the resulting implications for compliance, liability, and risk management.
• Early enforcement trends, including the most frequently cited FDA Form 483 observations and how they may be interpreted by regulators, litigators, and insurers.
• Practical recommendations for moving forward, including low-cost compliance improvements, larger quality system initiatives, and areas that may influence regulatory outcomes, litigation defensibility, and insurance underwriting decisions.

This session is designed for medical device manufacturers, attorneys, expert witnesses, risk managers, and insurance professionals seeking to understand how the transition to QMSR may affect regulatory compliance, product liability exposure, and organizational risk.