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Communication Dans Un Congrès Année : 2024

Promote Competency-Based Training Approach in Quality, Regulatory and Clinical Affairs to Improve MD/IVDD Safety and Performance

Vincent Armbruster
Jan-Hinnerk Mehrkens
Monique Borel
  • Fonction : Auteur
Marlène Durand

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.
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hal-04501305 , version 1 (12-03-2024)

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Paternité - Pas d'utilisation commerciale - Pas de modification

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Lionel Pazart, Vincent Armbruster, Debora Monin, Jan-Hinnerk Mehrkens, Monique Borel, et al.. Promote Competency-Based Training Approach in Quality, Regulatory and Clinical Affairs to Improve MD/IVDD Safety and Performance. Special Session on European Regulations for Medical Devices: What Are the Lessons Learned after 1 Year of Implementation?, Feb 2024, Rome, Italy. ⟨10.5220/0012593900003657⟩. ⟨hal-04501305⟩
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