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 Akademie GmbH training program “In-Vitro-Diagnostics Expert (TÜV)”, recognized by the certification body consisting of the following modules:

  • Design and Development of In-Vitro-Diagnostics (IVD) (8 teaching units)
  • CE-Marking for In-Vitro-Diagnostics (8 Teaching units)
  • Risk management and usability of IVD (8 teaching units)
  • Performance evaluation and performance evaluation monitoring of IVD (8 teaching units)

Admission to the exam is granted upon a minimum attendance of 80%.

Examination Components:

Written examination (multiple choice)

Required Competencies:

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

  • Development
  • CE-Marking
  • Risk Management
  • Performance Evaluation

Successful candidates have proven the necessary knowledge, in order to develop in-vitro-diagnostics according to the law and norms and introduce them onto the market. They are familiar with the essential requirements regarding process, content, as well as scope of documentation and depth of the conformity evaluation process. They can take the risk management and the usability correctly into account and update them during the complete life cycle. They know the procedure of performance evaluation and performance evaluation monitoring as proof of suitability for the respective purpose, indication and the fulfilment of performance data.