TM_005_FDA_rev 01

This course explains the FDA's role in the regulation of medical devices. It provides the definition of a medical device and describes the steps involved in bringing a new product to the US market, as well as the different types of pre-market regulatory submissions that may be required by the FDA.

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.