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Authors: Marion Burland 1 and Thierry Chevallier 2 ; 3 ; 4

Affiliations: 1 Department of Quality, Regulatory and Clinical Affairs, DEDIENNE Santé, Le Mas des Cavaliers, 217 rue Charles Nungesser, 34130 Mauguio, France ; 2 Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Place du Pr. Robert Debré, 30029 Nîmes, France ; 3 Tech4Health-FCRIN, France ; 4 UMR 1302, Institute Desbrest of Epidemiology and Public Health, INSERM, Univ Montpellier, Montpellier, France

Keyword(s): Massive Database, Real Life Study, Post-Market Clinical Follow up, Medical Device.

Abstract: With the application of new European regulations on medical devices in May 2021, the requirements for clinical evaluation have been strongly reinforced. Post-marketing clinical follow-up is now a key activity for manufacturers to keep their medical devices on the market. The use of material-epidemiology studies and real-life databases has multiple strengths and advantages. However, the weaknesses and limitations identified do not yet allow manufacturers (especially small and medium-sized companies) to fully utilize these tools for post-market clinical follow-up. Yet certain technological and regulatory developments already implemented, and to be implemented over time, suggest that these tools could play a crucial role in the clinical monitoring of medical devices in the future. In order to better define the future use of real-life data in post-market clinical follow-up activities, a comprehensive update of technological and regulatory surveillance is still required.

CC BY-NC-ND 4.0

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Paper citation in several formats:
Burland, M. and Chevallier, T. (2022). The Role of Massive Databases in the Post-market Clinical Follow-up of Medical Devices. In Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed; ISBN 978-989-758-552-4; ISSN 2184-4305, SciTePress, pages 243-249. DOI: 10.5220/0010952600003123

@conference{clinmed22,
author={Marion Burland. and Thierry Chevallier.},
title={The Role of Massive Databases in the Post-market Clinical Follow-up of Medical Devices},
booktitle={Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed},
year={2022},
pages={243-249},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010952600003123},
isbn={978-989-758-552-4},
issn={2184-4305},
}

TY - CONF

JO - Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed
TI - The Role of Massive Databases in the Post-market Clinical Follow-up of Medical Devices
SN - 978-989-758-552-4
IS - 2184-4305
AU - Burland, M.
AU - Chevallier, T.
PY - 2022
SP - 243
EP - 249
DO - 10.5220/0010952600003123
PB - SciTePress