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An Auditor's Take: Unrealistic EU Demands Are Causing Notified Body Exodus, Potential Company Collapses

 
• By Amanda Maxwell

Demands related to auditor education, experience and affiliation are making it difficult for notified bodies to retain and hire staff. This comes on top of much tougher regulatory requirements. One notified body auditor explains why the situation might be killing notified bodies when they are needed most.

Medtech Insight’s headlines have frequently focused on new tougher requirements for notified bodies that have come into place since 2013, and there is no sign that trend is letting up. Few individuals have been as frank and outspoken about the issue as Daniel Shoukier, lead auditor at notified body SQS, Switzerland

He provided his personal opinions on the matter at KNect Drug Device Combination Product meeting (convened by Medtech Insight publisher...

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More from Policy & Regulation

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• By Elizabeth Orr

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