ID No. 0000064050: Process Validation Expert Medical Devices (TÜV)

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Certification Program Title:Process Validation Expert Medical Devices (TÜV)
Admission Requirements:

Successful participation in the TÜV Rheinland Academy’s qualification “Process Validation Expert Medical Devices (TÜV)”, recognized by PersCert TÜV with the individual seminars

  • Validation of processes in the medical devices industry (8 teaching units) (seminar no. 09476)
  • Statistical methods in the medical devices industry (8 teaching units) (seminar no. 09520)
  • Workshop – validation of processes for medical devices (16 teaching units (seminar no. 09346)

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

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

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

  • Validation of processes in the medical devices industry
  • Statistical methods in the medical devices industry

Process Validation Experts Medical Devices (TÜV) have the necessary knowledge of relevant requirements, common models and statistical methods for the process validation in the context of medical device production. They can plan the required process validations, implement them while using the appropriate statistical method, as well as evaluate and document them (IQ:OQ:PQ). They ensure that the production processes for medical devices are developed safely and that these products work reliably throughout their entire product lifecycle. They ensure that the requirements of the standard ISO / EN ISO 13485 and the FDA requirement (QSR) are met.

Recertification:

In der Prüfung weisen die Teilnehmer Kenntnisse in folgenden Bereichen nach:

  • Validierung von Prozessen in der Medizinprodukteindustrie
  • Statistische Methoden in der Medizinprodukteindustrie

Process Validation Experts Medical Devices (TÜV) verfügen über die erforderliche Sachkenntnis der relevanten Vorgaben, gängigen Modelle und statistischen Methoden für die Prozessvalidierung im Rahmen der Herstellung von Medizinprodukten. Sie können die erforderlichen Prozessvalidierungen planen, unter Einsatz der richtigen statistischen Methode durchführen, auswerten und dokumentieren (IQ; OQ; PQ). Sie stellen sicher, dass die Herstellprozesse für die Medizinprodukte sicher entwickelt werden und dass diese Produkte und über den gesamten Produktlebenszyklus zuverlässig arbeiten. Sie stellen sicher dass die QM-Anforderungen der Norm ISO / EN ISO 13485 und der FDA-Vorgabe (QSR) erfüllt werden.

Currently implemented in:Germany