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

 

Register: https://lnkd.in/enqdjCd

 

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.