QMSR

The Quality Management System Regulation (QMSR) is the U.S. regulation of the quality management system for medical devices – 21 CFR Part 820, effective February 2, 2026. It replaces the previous Quality System Regulation by directly incorporating the requirements of ISO 13485:2016 – a QMS built on ISO 13485 thus fulfills the core of the U.S. obligation. Telling is the first obligation in § 820.10: it reads, literally, “Document.” – a verb: the QMS is to be documented, not a document to be delivered. The old document control section § 820.40 is gone ([Reserved]). For software in production and the QMS, the FDA CSA guidance describes the risk-based evidence approach under the QMSR.

See also: Computer Software Assurance (CSA), Quality Management.