QMSR (Quality Management System Regulation)

The Quality Management System Regulation is the FDA rule that updates 21 CFR Part 820 by incorporating ISO 13485:2016 as the core quality-system requirements for medical devices.

For many years, US manufacturers lived with the Quality System Regulation in Part 820 and, separately, with ISO 13485 for other markets. The QMSR reduces that double system by pointing the US regulation at ISO 13485, with additional FDA-specific requirements that the rule keeps. The practical effect for a quality lead is that the clauses you already audit for 13485 are the clauses an investigator will recognize, provided you also meet the definitions, records and reporting duties FDA did not drop.

QMSR is not a reason to throw away device history records, complaint files or medical device reporting. Those duties sit beside the quality system. It is a reason to stop maintaining two conflicting procedure sets, one written in old 820 language and one written in 13485 language.

HAVGATE audits can cite ISO 13485 and the QMSR together. The MDSAP checklist already carries 21 CFR Part 820 references on tasks, which is the bridge while teams update procedure titles from the old QSR to the QMSR.