The Medical Device Risk Management Standard - What’s New with ISO 14971:2019? - By Michael B. Checketts
Risk management plays a prominent role in the development of medical devices. The long-awaited Risk Management standard (ISO 14971, 3rd Ed.) was released for publication in late 2019. In addition, there is a new companion guidance document released, known as ISO/TR 24971:2019. Download this article by our top consultant, Michael B. Checketts, to get a full glimpse of the Medical Device Risk Management Standard and its notable changes with ISO 14971:2019.