QMSR
FDA QSR & ISO 13485 Harmonization
Medical Device Companies Need to Prepare
The FDA announced the most significant revisions in FDA’s quality system requirements for medical devices in decades. Medical Device companies have until February 2, 2026, to comply. Don’t wait. Acting now to determine what you need to do to comply will save you money and make any transition happen without disruption to your business.
The final rule amends 21 CFR Part 820 by requiring compliance with ISO 13485, plus additional requirements that are necessary to satisfy the Food, Drug & Cosmetic Act (FDCA). The final rule also incorporates by reference Clause 3 of ISO 9000.
Even though, the FDA maintains that the QMSR does not fundamentally alter the requirements under the QSR, and that the scope of the QMSR is unchanged the Final Rule reveals more than just cosmetic changes to Part 820.
Unlike changes to the ISO standard’s revisions, the FDA is not providing a comparison matrix between the QSR and the new QMSR.
There are actions medical device companies can take to begin the transition to the QMSR. Acting now will make your transition smoother and less costly.
Quality System Consultants can help. CONTACT US TODAY!