ISO 14971 is an international standard that outlines the requirements for risk management in medical devices. It provides guidance on identifying, analyzing, evaluating, and controlling risks associated with medical devices throughout their entire lifecycle. The standard is applicable to all types of medical devices, including software and in vitro diagnostic devices.
ISO 14971 is an important standard for medical device manufacturers as it is required by certain regulatory bodies for demonstrating compliance with their respective regulations. It is also a key component of the quality management system for medical devices outlined in ISO 13485.