Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

ISO 13485 Revision Coming

Posted by crimsonlanguage on 2013/05/13

Delegates to ISO TC 210 report that ISO 13485, the quality systems standard for medical device manufacturers, will be revised on 17 (or more) topic points.

Since the decision was just taken by the technical committee, the actual revisions are a way out, but manufacturers who want to have meaningful input are advised to get involved now.

Crimson was the first translation supplier to register to ISO 13485 and ISO 14971.


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