Combined Medical Devices: Which Classification for These Borderline Products and Which Consequences for the Manufacturers - About a Use Case in Skin Healing Area

Vaissière Anaïs, Chevallier Thierry, Chevallier Thierry, Chevallier Thierry

2022

Abstract

Skin healing is a rapidly expanding field, especially with the growing needs of an aging population and the increase in chronic pathologies (diabetes, venous ulcers, bedsores etc...). In order to offer ever more adapted solutions, manufacturers are competing in ingenuity to propose innovative medical devices that meet the expectations of patients, caregivers and the healthcare system. These developments raise many questions, particularly with regard to the classification of devices in the various risk classes and the naming of these wound healing devices. This article will focus on combined medical devices with the difficulties they pose for manufacturers and health authorities in terms of development, financial investment, risk-taking and the difficulty of classifying these so-called borderline products in the medical device universe.

Paper Citation

in Harvard Style

Anaïs V. and Thierry C. (2022). Combined Medical Devices: Which Classification for These Borderline Products and Which Consequences for the Manufacturers - About a Use Case in Skin Healing Area. In Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed, ISBN 978-989-758-552-4, pages 281-288. DOI: 10.5220/0010937300003123

in Bibtex Style

@conference{clinmed22,
author={Vaissière Anaïs and Chevallier Thierry},
title={Combined Medical Devices: Which Classification for These Borderline Products and Which Consequences for the Manufacturers - About a Use Case in Skin Healing Area},
booktitle={Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,},
year={2022},
pages={281-288},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010937300003123},
isbn={978-989-758-552-4},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,
TI - Combined Medical Devices: Which Classification for These Borderline Products and Which Consequences for the Manufacturers - About a Use Case in Skin Healing Area
SN - 978-989-758-552-4
AU - Anaïs V.
AU - Thierry C.
PY - 2022
SP - 281
EP - 288
DO - 10.5220/0010937300003123