21 CFR 820 and ISO 13485:2016 Harmonization: Getting Ready for the QMSR​

The purpose of this document is to provide recommendations for the transition of 21 CFR 820 to harmonization with ISO 13485:2016. This document is intended for current users of 21 CFR 820, those who will require adaptation to ISO 13485:2016, as well as other interested parties. These parties include, but are not limited to, medical device manufacturers, accreditation bodies, certification bodies, registrars, and regulatory authorities that include the use of 21 CFR 820.