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Updated ISO 13485 for Medical Devices: What is Changing?

Eamonn Hoxey – Mar 23, 2016

Medical DocumentsISO 13485 defines requirements for a quality management system (QMS) for regulatory purposes for organizations involved in the supply chain and lifecycle of medical devices.

The third edition of ISO 13485 was made available at the end of February 2016 with a publication date of 1st March 2016 and replaces the second edition from 2003. It has a number of changes to reflect the evolving regulatory expectations applying to these medical device organizations.

Read more to find out who is affected and what has changed with the third edition of ISO 13485?

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