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The international quality management system (QMS) standard for medical devices, ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes) and the European Standard version, EN ISO 13485:2016, were published on March 1, 2016.

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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