ID No. 0000042418: Expert Technical Documentation Medical Devices (TÜV)

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Certification Program Title:Expert Technical Documentation Medical Devices (TÜV)
Admission Requirements:

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.

Examination Components:
  • Written Examination (Multiple Choice)
Required Competencies:

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.

Currently implemented in:Germany