Medical Device Risk Management

The medical device risk management standard ISO 14971 was updated to the Third Edition, ISO 14971:2019, and released in December 2019.  FDA quickly Recognized the standard and CEN, the European standards body released EN 14971:2019 in December also. Discussed in the standard is that risk management consists of several elements forming a system, a risk management process, responsible management, competent personnel, a risk management plan, and a risk management file containing the results of the risk management activities.  As our medical devices become more complex, it is important that we view the devices themselves as a system consisting of many parts, requiring a systematic approach to risk management.