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.
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- What’s new
- What hasn’t changed
- Answers to some common organizational scenarios