Editorial Contributor

Karen Howes, Director of Regulatory Affairs, European Diagnostic Manufacturers Association
Karen Howes, Director of Regulatory Affairs, European Diagnostic Manufacturers Association

Karen Howes is an expert in the field of medical device regulation, having first worked at the EU Commission in the medical devices sector from June 1996 until June 2003, contributing to the development of the in-vitro diagnostic medical devices directive 98/79/EC, the review of the medical devices directive and providing advice on medical device matters.

She then spent four years working in Brussels for the European Diagnostic Manufacturers Association (EDMA) as the director of regulatory affairs, working on regulatory matters affecting the EU IVD industry.

Report to Reduce Harm

Safety comes first: vigilance guidelines must be followed by all manufacturers to reduce the risk of patient incidents.



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