FAQs
Inspection Readiness & Quality Systems
Q8: What changed under QMSR and does our ISO 13485 certification still satisfy FDA?
The transition harmonizes U.S. device QMS requirements with the international standard. However, it does not mean that ISO 13485 certification alone satisfies QMSR.
FDA has clearly stated that ISO 13485 certification does not exempt a manufacturer from FDA inspection. Companies can be fully certified and still receive FDA Form 483 observations if they do not recognize the FDA’s additional requirements.
Six months into QMSR enforcement, the most consistent finding is that companies that treated the transition as a documentation renaming exercise are encountering inspection gaps. A significant difference between the legacy QSR requirements and the new QMSR is considerably more emphasis on product lifecycle risk management based on ISO 13485 and ISO 14971:2019: Medical Devices — Application of Risk Management. Landrich Group supports QMSR gap assessments and mock audits calibrated to the new inspection framework and providing confidence for ensuring FDA inspection readiness.