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 the personnel certification body, with the single seminars to be attended within a 3-year period

  • Validation of processes in the medical devices industry (event no. 09476)
  • Statistical methods in the medical devices industry (event no. 09520)
  • Workshop – Validation of processes for medical devices (event no.. 09346)

Admission to the examination is granted upon a minimum attendance of 80% per single seminar with a combined total of 32 teaching units.

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

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

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

Candidates with the qualification „Process Validation Expert Medical Devices (TÜV)” have the required knowledge of relevant requirements, common models and statistical methods for process validation in the context of the production of medical devices. They can plan the necessary process validations, implement them while using the appropriate statistical method, evaluate and document them (IQ; OQ; PQ). They ensure that production processes for medical devices are developed safely and that the products function reliably throughout the entire product life cycle. They ensure that the QM requirements according to 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