Identyfikator 0000042418: Expert Technical Documentation Medical Devices (TÜV)

Tytuł kwalifikacji: | Expert Technical Documentation Medical Devices (TÜV) |
Wymagania wstępne: | Successful participation in the TÜV Rheinland Academy’s qualification „Expert Technical Documentation Medical Devices (TÜV)“, recognized by PersCert TÜV, with the individual seminars:
all of which have to be completed within a maximum period of three years. Admission to the examination is granted upon a minimum attendance of 80% of the 40 teaching units. |
Składowe egzaminów: |
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Wymagane kompetencje: | In the examination, the candidates prove their knowledge in the following areas:
“Experts Technical Documentation Medical Devices (TÜV)” are familiar with the approach and the essential steps of the CE-marking process. They can develop the technical documentation in a systematic and structured manner, taking into account clinical evaluation and risk management. They can also and update it throughout its lifecycle, thus ensuring the smooth cooperation with the notified body. |
Currently implemented in: | Niemcy |