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Authors: Thomas Lihoreau 1 ; Chrystelle Vidal 1 ; Tianguang Wang 2 and Lionel Pazart 1

Affiliations: 1 CHU Besançon, INSERM CIC 1431, Centre d'Investigation Clinique, Besançon, France ; 2 Institut Supérieur d'Ingénieurs de Franche-Comté, University of Franche-Comté, Besançon, France

Keyword(s): High Risk Medical Devices, Evaluation, Methodology.

Abstract: Medical devices are developed by manufacturers that need to provide proofs of safety, efficacy, efficiency. In the same time they could be specialists in the technologies, they could not be necessary experts for the targeted medical field and need to be surrounded to build the correct clinical evaluation strategy. Skills required are specific to these particular instruments, and need to be optimized and innovative, as there is as much different devices than the start-ups in the arena. Even if works are performed on the methodological aspects since years, we propose to state a snap of the situation thanks to clinical trials databases exploration, with the aim to extract typical cases for future help and support for the actors. The current article offer to present our strategy of work as well as first quantitative results.

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Paper citation in several formats:
Lihoreau, T.; Vidal, C.; Wang, T. and Pazart, L. (2021). Exloration of High Risk Medical Devices Methodologies for Optimized Evaluations. In Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed; ISBN 978-989-758-490-9; ISSN 2184-4305, SciTePress, pages 285-289. DOI: 10.5220/0010386502850289

@conference{clinmed21,
author={Thomas Lihoreau. and Chrystelle Vidal. and Tianguang Wang. and Lionel Pazart.},
title={Exloration of High Risk Medical Devices Methodologies for Optimized Evaluations},
booktitle={Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed},
year={2021},
pages={285-289},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010386502850289},
isbn={978-989-758-490-9},
issn={2184-4305},
}

TY - CONF

JO - Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed
TI - Exloration of High Risk Medical Devices Methodologies for Optimized Evaluations
SN - 978-989-758-490-9
IS - 2184-4305
AU - Lihoreau, T.
AU - Vidal, C.
AU - Wang, T.
AU - Pazart, L.
PY - 2021
SP - 285
EP - 289
DO - 10.5220/0010386502850289
PB - SciTePress

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