The revised standard for medical devices, ISO 13485:2016 and the European Standard version, EN ISO 13485:2016, were published earlier this year allowing a three-year transition period that will apply to all existing certificates.
This guide is intended as a starting point for medical device manufacturers currently certified to an existing version of ISO 13485 and are considering what steps to take towards a smooth transition to the new and revised standard, including manufacturers using EN ISO 13485 for presumption of conformity with the quality system requirements of the medical devices directives.
Download now and find out:
- What’s new
- What hasn’t changed
- Answers to some common organizational scenarios
Contact us to learn more about ISO13485:2016 transition training