TM 001 Risk Management FR

TM_001_Risk Management rev 01

This training explains the different requirements expected from ISO 14971:2019.
This training is in several stages:
- Risk management process
- Risk analysis
- Risk Assessment (estimation + evaluation)
- Risk control

At the end of the training, a questionnaire must be completed by the employee (hot evaluation).
If they obtain the training certificate, we consider that they are autonomous to carry out these tasks.
If you don't get enough points, further training will be organised with the responsible of this training.

No cold assessment is necessary.