[FEATURED] Updated Version Of EN ISO 13485 Now Officially Harmonized Under MDR Along With Other Standards

The New Year has seen the official publication of a series of long-awaited new medtech standards, including some that are critical to large swathes of the medical device industry.

It’s official! The updated version of the EU quality system standard EN ISO 13485, which is relevant for the whole of the medtech industry, is now formally recognized as a “harmonized” standard in the context of the EU’s Medical Device Regulation.

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