ISO 14971 is an international risk management standard for medical devices (including in vitro diagnostic medical devices). It defines a set of medical device risk management requirements. Risk management of medical devices is an important aspect to of ensuring that medical devices are designed to be safe and effective, thus demonstrating compliance with the various medical device directives/ regulations and administrations throughout the world. The purpose of this standard is to help manufacturers to establish a medical device risk management process in identifying the hazards associated with medical devices, assessing the corresponding risks, controlling these risks where needed, and monitoring the effectiveness of the risk control measures.
