TM 001 01 Introduction to Risk management for medical devices
Introduction to risk management for medical devices permit to have the general overview of ISO 14971 requirements
TM_001_01 rev 01
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.