ID号码 0000045047: Expert Medical Software (TÜV)

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认证项目名称:Expert Medical Software (TÜV)
入学要求:

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.

考试内容:
  • Written examination (multiple choice)
必需具备的能力:

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.

目前适用地区:德国