ISO 14971 (Medical Devices)

ISO 14971 is an international standard that provides guidelines for the risk management of medical devices. It outlines a systematic approach for identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. This includes analyzing how risks might affect users and patients, implementing measures to mitigate those risks, and ensuring that any residual risks are acceptable. The standard helps manufacturers make safer devices and assures regulatory bodies that proper safety measures are in place, ultimately protecting public health and ensuring effective medical care.