QMSR Blog
QSR-to-QMSR Blog
The transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) represents one of the most significant regulatory developments affecting medical device manufacturers in recent years.
As the FDA aligns its device quality system framework with ISO 13485:2016, manufacturers must understand not only what the regulation requires, but how those requirements affect quality system implementation, inspections, and regulatory strategy.
Our goal is to translate complex regulatory developments into clear, practical insights that help organizations build effective and inspection-ready quality systems.
Staying Informed
The QMSR transition will continue to evolve as manufacturers adapt their quality systems and as FDA inspection practices develop under the new regulatory framework. This blog will continue to publish insights, analysis, and guidance to help organizations remain informed and prepared.
The QMSR Blog
Complaint Handling and Post-Market Surveillance Under QMSR
Complaint Handling and Post-Market Surveillance Under QMSRComplaint handling and post-market surveillance are critical elements of medical device quality systems. While design controls ensure devices are properly developed and manufactured, complaint handling ensures...
Design Controls in the ISO 13485 Framework
Supplier Quality in the QMSR EraWhat Changes Under QMSR Design controls have long been a central pillar of medical device regulation. Under the legacy Quality System Regulation (QSR), FDA established detailed requirements for design planning, verification, validation,...
CAPA Under QMSR
Supplier Quality in the QMSR EraThe Most Inspected Process in Medical Device Quality Systems Corrective and Preventive Action (CAPA) has long been one of the most scrutinized elements of medical device quality systems. Under the legacy Quality System Regulation (QSR),...
Supplier Quality in the QMSR Era
Supplier Quality in the QMSR EraWhy Supplier Controls Are Becoming a Strategic Risk Function Supplier quality management has long been one of the most misunderstood areas of medical device regulation. Under the legacy Quality System Regulation (QSR), many...
Risk Management Under QMSR
Why Risk Management Matters More than EverFor many medical device manufacturers operating under the legacy Quality System Regulation (QSR), risk management was often treated primarily as a design control activity. Risk analyses were typically performed during product...