Identyfikator 0000027230: Expert Quality Management Medical Devices International (TÜV)

Strona jest dostępna w innych językach: German
Tytuł kwalifikacji:Expert Quality Management Medical Devices International (TÜV)
Wymagania wstępne:

Successful participation in the TÜV Rheinland Academy’s course „Expert Quality Management Medical Devices International (TÜV)”, recognized by PersCert TÜV with the individual modules:

  • QM Representative for medical devices according to EN ISO 13485 (8 teaching units)
  • Quality Management according to EN ISO 13485:2016 (8 teaching units)
  • Quality Management System according to 21 CFR Part 820 (QSR – USA) (8 teaching units)
  • Risk Management according to ISO 14971:2019 / EN ISO 14971 (8 UE)
  • CAPA & Co for manufacturers of medical devices (8 teaching units)

All modules have to be completed within a maximum of 3 years.

Składowe egzaminów:
  • Written exam (multiple choice)
Wymagane kompetencje:

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

  • Quality Management Systems in the medical devices industry
  • Risk Management
  • Corrective and preventive action system
  • Tasks and responsibilities of Quality Management Representatives

Experts Quality Management Medical Devices International (TÜV) are familiar with the requirements regarding quality management systems and risk management. They can responsibly support the implementation, documentation and further development of a QM System, compliant with standards. They can steer and document a QM System and monitor its effectiveness. They are capable of fulfilling the role of a Quality Management Representative.

Obecnie wdrożony w:Niemcy