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 Akademie qualification „Expert Technical Documentation Medical Devices (TÜV)“ recognized by the certification body comprising the following individual seminars

  • Design and development of medical products (8 teaching units)
  • Technical documentation medical products (8 teaching units)
  • CE marking processes for medical devices (8 teaching units)
  • Clinical evaluation and inspection of medical products (8 teaching units)
  • Risk management according to EN ISO 14971 (8 teaching units)

within a period of 3 years.
Admission to the examination is granted on a minimum attendance of 80%.

Examination Components:

Written examination (multiple choice)

Required Competencies:

In the exam participants prove their knowledge in the following areas:

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

“Experts Technical Documentation Medical Devices (TÜV)” are familiar with the approach and the essential steps in the CE marking process for medical devices. They can structure the technical documentation while considering clinical evaluation and risk management systematically. Furthermore they can keep the documentation up to date throughout the complete product life cycle thus enabling smooth cooperation with their notified body.