ISO13485:2016 – The Story of Narcissus

The medical Device Companies – and especially a lot of their Quality/Regulatory Affairs departments – hoped, right until the end, that the updated 13485:2016 standard would be merged with the new 9001:2015 approach and structure. A common approach supporting the entire company and all its processes – internally as well as externally.   ISO9001:2015 – […]

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