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Authors: Stéphanie Py 1 ; Thomas Lihoreau 1 ; Marc Puyraveau 1 ; Sylvain Grosdemouge 2 ; Nadia Butterlin 3 ; Stéphanie Francois 3 ; Morgane Eveilleau 3 ; Aurélie Camelio 4 ; Gérard Thiriez 4 ; Floriane Ciceron 5 and Pauline Ecoffet 4

Affiliations: 1 CHU Besançon, INSERM CIC 1431, Centre d'Investigation Clinique, Besançon, France ; 2 Shine Group, Châtillon-le-Duc, France ; 3 Univ. Bourgogne Franche-Comté, Institut Supérieur d'Ingénieurs de Franche-Comté ISIFC, Besançon, France ; 4 CHU Besançon, Department of Pediatric Intensive Care Unit, Besançon, France ; 5 Univ. Bourgogne Franche-Comté, Plateforme Centre de Simulation Universitaire en Santé CESIUS, Besançon, France

Keyword(s): High Risk Medical Device, Software, Pediatric Intensive Care, Clinical Investigation.

Abstract: Caring for a child in life-threatening distress is very stressful and error-prone for the caregivers. An end-user need for a software that would free the child from human error and support the caregivers in the care of the child has thus emerged. Free from the time-consuming and stressful constraints of calculating constants or medication doses and consulting emergency protocols, caregivers could be more available and focused on the vital care of the child. The extension of the scope of medical devices to software for medical purposes is one of the important new points of the future European regulations. The very important overhaul of the previous classification system with the addition of new rules or updating of old ones reinforces the regulations applicable to software. The impact is considerable for the development and market access strategy of high-risk classified software, and participate in a better security and efficacy of the marketed products, for better healthcare. In this article we propose then to detail the strategy used for the development of a high-risk medical device software intended to be used in pediatric intensive care units. (More)

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Paper citation in several formats:
Py, S.; Lihoreau, T.; Puyraveau, M.; Grosdemouge, S.; Butterlin, N.; Francois, S.; Eveilleau, M.; Camelio, A.; Thiriez, G.; Ciceron, F. and Ecoffet, P. (2021). Meeting an End-user Need in a Collaborative High Risk Medical Device Software Development in Accordance with Future European Regulations. 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 265-273. DOI: 10.5220/0010381502650273

@conference{clinmed21,
author={Stéphanie Py. and Thomas Lihoreau. and Marc Puyraveau. and Sylvain Grosdemouge. and Nadia Butterlin. and Stéphanie Francois. and Morgane Eveilleau. and Aurélie Camelio. and Gérard Thiriez. and Floriane Ciceron. and Pauline Ecoffet.},
title={Meeting an End-user Need in a Collaborative High Risk Medical Device Software Development in Accordance with Future European Regulations},
booktitle={Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed},
year={2021},
pages={265-273},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010381502650273},
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 - Meeting an End-user Need in a Collaborative High Risk Medical Device Software Development in Accordance with Future European Regulations
SN - 978-989-758-490-9
IS - 2184-4305
AU - Py, S.
AU - Lihoreau, T.
AU - Puyraveau, M.
AU - Grosdemouge, S.
AU - Butterlin, N.
AU - Francois, S.
AU - Eveilleau, M.
AU - Camelio, A.
AU - Thiriez, G.
AU - Ciceron, F.
AU - Ecoffet, P.
PY - 2021
SP - 265
EP - 273
DO - 10.5220/0010381502650273
PB - SciTePress

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