Risk Management process according to ISO 14971 plays a fundamental role for medical device QMS. Specifically, with the new changes on the ISO 14971 version 2019, you need to have a procedure in your QMS that takes in consideration all the new requirements. Here you can find an example of Risk Management procedure.
Moreover, the procedure takes in consideration all the aspects of risk management process, from risk evaluation to risk control.
In conclusions: do not hesitate to purchase this procedure and include it in your Quality Management System.
- Risk Management Procedure€79,00