ISO Transition Planning Guidance for ISO 13485:2016

This document was created and distributed by the International Organization for Standardization. They state: “The purpose of this document is to provide recommendations for transition to the application of ISO 13485:2016 globally. This document is intended for current users of ISO 13485:2003 (Ref. 1), those who are intending to use 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, regulatory authorities responsible for implementation and surveillance of medical device regulatory requirements that will include the use of ISO 13485:2016, and international and national standards bodies.”