The FDA's Quality Management System Regulation establishes comprehensive good manufacturing practice (CGMP) requirements for medical device manufacturing. Through the final rule effective February 2, 2026, the QMSR incorporates by reference ISO 13485:2016, aligning FDA requirements with international quality management standards. The regulation covers design and development controls (equivalent to 21 CFR 820.30), manufacturing operations, documentation, and management oversight across the entire device lifecycle. Key requirements include design input and output specifications, design review and verification, design validation, design transfer, and identification and implementation of design changes. The QMSR serves as a foundational regulatory framework for simultaneous FDA and Japanese approval pathways, establishing baseline quality system compliance expectations for manufacturers seeking marketing authorization in multiple regions. Compliance with these requirements demonstrates commitment to systematic quality assurance throughout device development and commercialization.