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Authors: Norbert Noury 1 ; Emmanuel Perrin 1 and Claire Gaillard 2

Affiliations: 1 Université de Lyon, Polytech Engineer School, Villeurbanne, France ; 2 Université de Lyon, Université Claude Bernard Lyon I, INSA Lyon, CNRS, MATEIS, UMR5510, 69008 Lyon, France

Keyword(s): Medical Devices, Regulatory Affairs, Education.

Abstract: The Medical devices industry is facing a shortage in the professionals in Regulation Affairs who are in charge with the regulation steps to bring their MD to the market. The Master ATRDM at Polytech Lyon 1 University, France, was elaborated following a top-down approach based on the development of competencies of the learners, with an agile iterative process to update the contents.

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Paper citation in several formats:
Noury, N., Perrin, E. and Gaillard, C. (2024). A Skill based Educational Program for Future Regulatory Affairs Professionals in the Medical Devices Industry: A Top down Approach at Polytech Lyon University, France. 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 858-863. DOI: 10.5220/0012616100003657

@conference{clinmed24,
author={Norbert Noury and Emmanuel Perrin and Claire Gaillard},
title={A Skill based Educational Program for Future Regulatory Affairs Professionals in the Medical Devices Industry: A Top down Approach at Polytech Lyon University, France},
booktitle={Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed},
year={2024},
pages={858-863},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0012616100003657},
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 - A Skill based Educational Program for Future Regulatory Affairs Professionals in the Medical Devices Industry: A Top down Approach at Polytech Lyon University, France
SN - 978-989-758-688-0
IS - 2184-4305
AU - Noury, N.
AU - Perrin, E.
AU - Gaillard, C.
PY - 2024
SP - 858
EP - 863
DO - 10.5220/0012616100003657
PB - SciTePress