Successful participation in the TÜV Rheinland Academy’s qualification „Expert Technical Documentation Medical Devices (TÜV)“, recognized by PersCert TÜV, with the individual seminars:

• Design and development of medical devices (8 teaching units) (seminar no. 09454)
• Technical documentation medical devices (8 teaching units) (seminar no. 09361)
• CE-marking processes for medical devices (8 teaching units) (seminar no. 09455)
• Clinical evaluation and trial of medical devices (8 teaching units) (seminar no. 09458)
• Risk management according to EN ISO 14971 (8 teaching units) (seminar no. 09471)

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.

• Written Examination (Multiple Choice)

In the examination, the candidates prove their knowledge in the following areas:

• Design and development
• Risk management
• Technical documentation
• Clinical evaluation and trial
• CE-marking process

“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.