Promote Competency-Based Training Approach in Quality, Regulatory and Clinical Affairs to Improve MD/IVDD Safety and Performance
Résumé
The aim of this paper is to analyze the training needs introduced by the implementation of the European regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and to analyze the appropriateness of a competency-based training approach. Finally, a number of ideas are put forward concerning certain topics to be addressed in a Europe-wide approach.
Origine | Fichiers produits par l'(les) auteur(s) |
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