Compliance with ISO 14155 serves the safety of patients during clinical trials

Meet Danielle Giroud, convener of the ISO expert group on clinical investigations, at the OCRA Orange County Regulatory Affairs Discussion Group, June 19th event on ISO:14155:2019




Medical devices may only be placed on the market if their performance and safety have been clinically evaluated. The harmonized standard ISO 14155:2019 “Clinical testing of medical devices for humans – good clinical practice” comprehensively regulates the performance of such trials.


The third edition of the standard, ISO 14155:2019 is expected to be published mid 2019.

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