ID No. 0000045047: Expert Medical Software (TÜV)

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Certification Program Title:Expert Medical Software (TÜV)
Admission Requirements:

Successful participation in the TÜV Rheinland Akademie GmbH qualification “Expert Medical Software (TÜV)” recognised by the certification body consisting of the following individual seminars:

  • Seminar “Development of Medical Software” (8 teaching units)
  • Seminar “CE Marking of Medically Used Software” (8 teaching units)
  • Seminar “Agile Methods for the Development of Medical Software” (8 teaching units)
  • Seminar “Suitability for Use of Medical Software” ( 8 teaching units)
  • Seminar “Risk Management According to ISO/EN ISO 14971” (8 teaching units)

Admission to the exam 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:

  • Development
  • CE marking
  • Agile methods
  • Suitability for use
  • Risk management

Successful participants are in a position to develop medical software in conformance with norms. They are familiar with the characteristics of the development of medical software. They also know the most important models for software development and can apply agile methods for software development. They are in a position to consider risk management and suitability for use appropriately and efficiently and implement the various process specifications.

Currently implemented in:Germany