T
Hi mates,
In order to comply with ISO13485, we shall develop the risk management for our medical devices. Our risk management file has cover the overall contents in conducting risk management and the result + report of the risk management conducted.
Is necessary or mandatory to have a documented procedure for risk management? (As all the steps and procedure have written in our existing risk management file). If so, what should be the contents of this risk management procedure?
This issue have been raised by our third party auditor and we explain that is written in the Risk Management File, but he don't accept!

Tiff
In order to comply with ISO13485, we shall develop the risk management for our medical devices. Our risk management file has cover the overall contents in conducting risk management and the result + report of the risk management conducted.
Is necessary or mandatory to have a documented procedure for risk management? (As all the steps and procedure have written in our existing risk management file). If so, what should be the contents of this risk management procedure?
This issue have been raised by our third party auditor and we explain that is written in the Risk Management File, but he don't accept!

Tiff