ID No. 0000038860: Medical Devices Usability Expert (TÜV)

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

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

  • Design and development of medical devices (8 teaching units) (seminar no. 09454
  • Risk management according to EN ISO 14971 (8 teaching units) (seminar no. 09471
  • Usability of medical products (8 teaching units) (seminar no. 09470)
  • User-centered design of medical devices (16 teaching units) (seminar no. 09347)

all of which have to be completed within a maximum of three years. Admission to the examination is granted upon a minimum attendance of 80% of the 40 teaching units.

Examination Components:
  • Written exam (multiple choice)
Required Competencies:

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

  • Design and development
  • Risk management according to DIN EN ISO 14971
  • Usability of medical devices
  • User-oriented design

Medical Devices Usability Experts are familiar with all relevant provisions, standards and processes for the analysis, development and design, verification and validation of the usability and design of medical devices. As a result they are capable of applying and implementing the requirements of the Usability Engineering process professionally. 

Currently implemented in:Germany