Compliance Training for Medical Device Manufacturers: FDA 21 CFR 820 Quality System, ISO 13485, and OSHA Documentation
Medical device manufacturers now train against a harmonized quality framework: as of February 2, 2026, FDA's Quality Management System Regulation amends 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, so personnel-competence and training records have to satisfy both at once. On top of that quality-system obligation, a production