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

Lionel Pazart; Vincent Armbruster; Debora Monin; Corinne Delorme; Monique Borel; Damien Nihouannen; Frédéric Barbot; Fabrice Bouquet; Guy Carrault; Thomas Lihoreau; Marlène Durand; Helène Clogenson; Sylvia Pelayo; Sylvia Pelayo

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Paper

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

Topics: (In Vitro) Medical Devices; Education; Regulations

In Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed, 842-851, 2024 , Rome, Italy

Authors: Lionel Pazart ¹ ; Vincent Armbruster ² ; Debora Monin ³ ; Corinne Delorme ⁴ ; Monique Borel ⁴ ; Damien Nihouannen ⁵ ; Frédéric Barbot ⁶ ; Fabrice Bouquet ⁷ ; Guy Carrault ⁸ ; Thomas Lihoreau ⁹ ; Marlène Durand ⁵ ; Helène Clogenson ¹⁰ and Sylvia Pelayo ^{9

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Affiliations: ¹ Université de Franche-Comté, UMR Inserm 1322 LINC & Inserm CIC 1431, F-25000 Besançon, France ; ² Université de Franche-Comté, Institut Supérieur d’Ingénierie de Franche-Comté F-25000 Besançon, France ; ³ Université de Franche-Comté, SUP-FC F-25000 Besançon, France ; ⁴ Syndicat National de l’Industrie des Technologies Médicales (SNITEM) F-92400 Courbevoie, France ; ⁵ Université de Bordeaux, F-33000 Bordeaux, France ; ⁶ Université de Versailles Saint-Quentin-en-Yvelines, Univ. Paris-Sud, F-78000 Versailles, France ; ⁷ Université de Franche-Comté, Institut FEMTO-ST UMR CNRS 6174 F-25000 Besançon, France ; ⁸ Université Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, CIC 1414, F-35000 Rennes, France ; ⁹ Tech4Health network – F-CRIN, France ; ¹⁰ Centre d’Investigation Clinique 1415, Centre Hospitalier Universitaire, F-37000 Tours, France ; ¹¹ Université de Lille, CHU Lille, ULR 2694 - METRICS, INSERM CIC-IT 1403, F-59000 Lille, France

Keyword(s): MDR, IVDR, Training, Regulatory Affairs, Clinical Investigation, Medical Device, CE Marking, Skills-Based Approach.

Abstract: 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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Paper citation in several formats:

Pazart, L.; Armbruster, V.; Monin, D.; Delorme, C.; Borel, M.; Nihouannen, D.; Barbot, F.; Bouquet, F.; Carrault, G.; Lihoreau, T.; Durand, M.; Clogenson, H. and Pelayo, S. (2024). Promote Competency-Based Training Approach in Quality, Regulatory and Clinical Affairs to Improve MD/IVDD Safety and Performance. In Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed; ISBN 978-989-758-688-0; ISSN 2184-4305, SciTePress, pages 842-851. DOI: 10.5220/0012593900003657

@conference{clinmed24,
author={Lionel Pazart. and Vincent Armbruster. and Debora Monin. and Corinne Delorme. and Monique Borel. and Damien Nihouannen. and Frédéric Barbot. and Fabrice Bouquet. and Guy Carrault. and Thomas Lihoreau. and Marlène Durand. and Helène Clogenson. and Sylvia Pelayo.},
title={Promote Competency-Based Training Approach in Quality, Regulatory and Clinical Affairs to Improve MD/IVDD Safety and Performance},
booktitle={Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed},
year={2024},
pages={842-851},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0012593900003657},
isbn={978-989-758-688-0},
issn={2184-4305},
}

TY - CONF

JO - Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed
TI - Promote Competency-Based Training Approach in Quality, Regulatory and Clinical Affairs to Improve MD/IVDD Safety and Performance
SN - 978-989-758-688-0
IS - 2184-4305
AU - Pazart, L.
AU - Armbruster, V.
AU - Monin, D.
AU - Delorme, C.
AU - Borel, M.
AU - Nihouannen, D.
AU - Barbot, F.
AU - Bouquet, F.
AU - Carrault, G.
AU - Lihoreau, T.
AU - Durand, M.
AU - Clogenson, H.
AU - Pelayo, S.
PY - 2024
SP - 842
EP - 851
DO - 10.5220/0012593900003657
PB - SciTePress