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

 
• By Amanda Maxwell

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.

Asphalt road with arrow guideline and Milestone letters painted on the surface. An image of a road milestones are representative of success in the future goal. Road to success with light of the sun

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.

It has been published in the Official Journal of the EU as giving a “presumption of conformity” with the MDR along with seven other standards, including the medical device...

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