Use of a Digital Positioning and Categorisation Aid for Clinical Investigations on Medical Devices: Questioning the Complexity of the Field and Harmonizing Stakeholders' Understanding.

Thierry Chevallier University of Montpellier, France https://orcid.org/0000-0002-5110-6273 Jean-Baptiste Pretalli Stéphanie Py Fatimata Seydou Sall Magali Nicolier Karine Charrière Thierry Chevallier Thomas Lihoreau Use of a Digital Positioning and Categorisation Aid for Clinical Investigations on Medical Devices: Questioning the Complexity of the Field and Harmonizing Stakeholders' Understanding. 864-871 2024 BIOSTEC (1) https://doi.org/10.5220/0012617600003657 conf/biostec/2024-1 db/conf/biostec/biostec2024-1.html#PretalliPSNCCL24 Carine Malle Alban De Luca Thierry Chevallier Medical Devices Used in Extreme Conditions in Pre-Hospital Emergency Medicine: Overview of the Issue, Use Case Regarding Mechanical Ventilation at Altitude and Advice. 215-221 2023 BIODEVICES https://doi.org/10.5220/0011923100003414 conf/biostec/2023bd db/conf/biostec/biodevices2023.html#MalleLC23 Arthur Trognon David Servais Islem Habibi Robert Picard Thomas Lihoreau Lionel Pazart Sylvia Pelayo Thierry Chevallier Kathryn Ernecq Anaïs Garin Mathias Béjean Denis Abraham Shaping User-Centered Health Innovation Through Assessment. 229-242 2023 BIODEVICES https://doi.org/10.5220/0011925800003414 conf/biostec/2023bd db/conf/biostec/biodevices2023.html#TrognonSHPLPPCE23 Marion Burland Thierry Chevallier The Role of Massive Databases in the Post-market Clinical Follow-up of Medical Devices. 243-249 2022 BIODEVICES https://doi.org/10.5220/0010952600003123 conf/biostec/2022bd db/conf/biostec/biodevices2022.html#BurlandC22 Marina Makeenko Thierry Chevallier Post-market Clinical Follow-up (PMCF) GAP Analysis for Legacy Devices Class III between the Medical Device Directive (MDD 93/42/EEC) and the Medical Device Regulation (MDR 2017/745). 273-280 2022 BIODEVICES https://doi.org/10.5220/0010889400003123 conf/biostec/2022bd db/conf/biostec/biodevices2022.html#MakeenkoC22 Anaïs Vaissière Thierry Chevallier Combined Medical Devices: Which Classification for These Borderline Products and Which Consequences for the Manufacturers - About a Use Case in Skin Healing Area. 281-288 2022 BIODEVICES https://doi.org/10.5220/0010937300003123 conf/biostec/2022bd db/conf/biostec/biodevices2022.html#AnaisT22 Lionel Pazart Sylvia Pelayo Thierry Chevallier Gabriel Gruionu Philippe Mabo Yves Bayon Frédéric Barbot Thomas Lihoreau Catherine Roussel Nicos Maglaveras Eirini Lekka Hugo Alexandre Ferreira Isabel Rocha Liesbet Geris C. Lavet Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations. 274-284 2021 BIODEVICES https://doi.org/10.5220/0010382902740284 conf/biostec/2021bd db/conf/biostec/biodevices2021.html#PazartPCGMBBLRM21 C. Vidal R. Beuscart Thierry Chevallier Contribution of Methodologies Adapted to Clinical Trials Focusing on High Risk Medical Devices. 337-343 2020 BIODEVICES https://doi.org/10.5220/0009374503370343 conf/biostec/2020bd db/conf/biostec/biodevices2020.html#VidalBC20 Denis Abraham Frédéric Barbot Yves Bayon Mathias Béjean R. Beuscart Marion Burland Karine Charrière Kathryn Ernecq Hugo Ferreira 0001Hugo Alexandre Ferreira Anaïs Garin Liesbet Geris Gabriel Gruionu Islem Habibi C. Lavet Irini LekkaEirini Lekka Thomas Lihoreau Alban De Luca Philippe Mabo Nicos Maglaveras Marina Makeenko Carine Malle Magali Nicolier Lionel Pazart Sylvia Pelayo Robert Picard Jean-Baptiste Pretalli Stéphanie Py Isabel Rocha Catherine Roussel Fatimata Seydou Sall David Servais Arthur Trognon Anaïs Vaissière C. Vidal