ID No. 0000050787: In-Vitro-Diagnostics Expert (TÜV)

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Certification Program Title:In-Vitro-Diagnostics Expert (TÜV)
Admission Requirements:

Successful participation in the TÜV Rheinland Academy’s qualification “in-Vitro-Diagnostics Expert (TÜV)”, recognized by PersCert TÜV with the individual seminars

  • Design and development of In-Vitro Diagnostics (IVD) 8 teaching units) (seminar no. 09503)
  • CE-marking for In-Vitro-Diagnostics (8 teaching units) (seminar no. 09343)
  • Risk management and usability of IVD (8 teaching units (seminar no. 09504
  • Performance assessment and performance evaluation of IVD (8 teaching units (seminar no. 09375)

which have to be completed within a maximum period of 3 years. Admission to the exam is granted upon a minimum attendance of 80% of the 32 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
  • CE-marking
  • Risk management
  • Usability
  • Performance assessment

In-Vitro-Diagnostics Experts (TÜV) can develop In-Vitro-Diagnostics in compliance with the law and standards and n them on the market. They are familiar with the essential requirements regarding process, contents as well as documentation, scope and depth of the conformity assessment process. They can adequately consider risk management and usability and update these throughout the entire lifecycle. They know the process of performance assessment and performance evaluation, as proof of the suitability for the respective purpose, and the indication and fulfillment of performance data

Currently implemented in:Germany