Europe's EN ISO 13485:2016 Out Now - But Another Review Expected In Three Years
This article was originally published in SRA
The EU version of ISO 13485:2016 - the revised international standard on medical device quality management systems - has been published, but device manufacturers will have to wait until EN ISO 13485:2016 gets "harmonized" before they can use it to claim compliance with the relevant aspects of the EU medical device directives1,2.
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