How to manage risk and clinical evaluation?

Answer:

In order to manage risk for the QMS, you will need to identify critical processes or parameters that will affect the safety and performance of the device that you are dealing with or the service that you will render for the medical device. This will be followed by a quick assessment using FMEA or any suitable matrix to assess the occurrence and severity in which you will also propose controls to mitigate the risk and implement them accordingly. All the information should be documented in a risk management report. What I have just summarized was basically in the following steps: Risk Analysis, Risk Evaluation, Risk Control, and Residual risk evaluation.

As for the clinical evaluation, you need to assess the safety and performance characteristics of the device that will affect its intended uses. You can base the evaluation on the IFU( Instructions For Use) that will be supplied to the client.

As per reference to ISO 11607, sterile barrier system means minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use.

For more information please read article:

How to use ISO 14971 to manage risks for medical devices
https://advisera.com/13485academy/blog/2017/09/21/how-to-use-iso-14971-to-manage-risks-for-medical-devices/