Risk Management helps ensure the safety of medical devices.There are many risks associated with the design & production of Medical Devices but also in their use.

Risk to safety of patients, users, handlers and Regulatory Product liability must all be managed.

Manufacturers must conduct and document a risk management process.ISO 13485 refers to ISO 14971 for guidance related to risk management.
The U.S.

Food and Drug Administration (FDA)
The EU has made it mandatory.