ID No. 0000045047: Expert Medical Software (TÜV)

The requested ID page is also available in the following languages: German
Certification Program Title:Expert Medical Software (TÜV)
Admission Requirements:

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

  • Development of Medical Software (8 teaching units)
    or
  • Development of Medical Software – EN 62304)  (8 teaching units)
  • CE-marking of Medical Software (8 teaching units)
  • Agile Methods for the Development of Medical Software (8 teaching units)
  • Usability of Medical Software (8 teaching units)
    or
  • Usability of Medical Software – EN 62366) (8 teaching units)
  • Risk Management according to ISO/EN ISO 14971 (8 teaching units)

the relevant ones of which have to be completed within a maximum of 3 years. Admission to the exam is granted upon a minimum attendance of 80% of the total of 32 teaching units

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

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

  • Development
  • CE-marking
  • Agile methods
  • Usability
  • Risk management

Experts Medical Software (TÜV) are capable of developing medical software in compliance with standards. They are familiar with the special features of development of medical software, know the main models for software development and can apply agile methods for the development of software. They are capable of considering risk management and usability in an appropriately efficient fashion and are additionally capable of implementing the wide range of process guidelines.

Currently implemented in:Germany