Risk Management File For Medical Devices: A risk management file is a comprehensive document detailing the potential risks associated with the use of a medical device. It describes each risk, including its severity and likelihood of occurrence, resulting from the device’s design, development, and testing activities. The purpose of this file is to provide detailed information for clinicians and health care providers to make informed decisions about the device’s use and safety. By understanding potential risks, manufacturers can ensure their devices are safe and effective for users.