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

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Título de la Cualificación:Expert Quality Management Medical Devices International (TÜV)
Requisitos de Admisión:

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

  • QM Representative for medical device manufacturers (8 teaching units)
  • Quality Management according to EN ISO 13485:2016 (8 teaching units)
  • Approval of medical devices for the USA – QSR or Quality Management System according to 21CFRPart820 (QSR-USA) (8 teaching units)
  • Risk Management according to EN ISO 14971 (8 UE)
  • CAPA & Co for manufacturers of medical devices (8 teaching units)

all of which have to be completed within a maximum of 3 years. Admission to the examination is granted upon a minimum attendance of 80% of the 40 teaching units.

Componentes de Examen:
  • Written exam (multiple choice)
Competencias Requeridas:

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.

Actualmente implementado en:Alemania