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

2024

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.

Paper Citation

in Harvard Style

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 - Volume 1: ClinMed; ISBN 978-989-758-688-0, SciTePress, pages 842-851. DOI: 10.5220/0012593900003657

in Bibtex Style

@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 - Volume 1: ClinMed},
year={2024},
pages={842-851},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0012593900003657},
isbn={978-989-758-688-0},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: 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
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