IMPLICATIONS FOR MEDTECH COMPANIES WITH FDA ROLLOUT OF THE NEW QMSR TO REPLACE CURRENT QSR

Tuesday, November 15, 2022 | 10 AM Central US Time

Brian Nguyen, SME, Medical Device QA RA
Celegence

FDA issuance of the new Quality Management System Regulation (QMSR) to industry is meant to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) with an incorporation by reference (IBR) to the 2016 edition of ISO 13485. FDA adoption of the ISO standard comes with some modification to maintain its statutory and regulatory framework. The transition is meant to be seamless as the ISO requirements are substantially similar with the QSR, however, such transition doesn’t go without possible impact to the existing QMS for integration and implementation of the new regulation.