Special Session
Special Session on
Dealing with the Change in European Regulations for Medical Devices -
ClinMed
2021
11 - 13 February, 2021
Within the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - BIOSTEC 2021
* CANCELLED *
CO-CHAIRS
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Lionel Pazart
Tech4Health/F-CRIN
France
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Brief Bio
Lionel Henri Pazart is a Medical Doctor (MD), Masters in Public Health (MPH), and associated Professor in Pharmacy. He is currently medical coordinator of Inserm Clinical Investigation Center on Innovative Technology at the University Hospital Besançon and teacher at the University of Health Sciences and at the School of Biomedical Engineering, University of Franche Comte, France. He is also an entrepreneur who contributed to launching 3 Start Ups, exploiting his work and (14) patents. He authored or co-authored more than 200 scientific papers, and is a recognized expert at the National and European level. He leads the Tech4Health network which is a component of the French national infrastructure of clinical research (F-CRIN) dedicated to medical devices investigation.
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Norbert Noury
University of Lyon
France
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Brief Bio
Norbert Noury is a Distinguished Professor at University of Lyon, France. His lectures cover Electronics and Physics in Medical devices and his research interests are in eHealth, connected health sensors, Ambient assistive living environments. After a MSc in Electronics (Grenoble University, 1985), he was R&D engineer in several industrial companies during 8 years. He then defended his PhD in Medical Telematics (1992) and joined the University of Grenoble (1993), where he initiated a new field of researches in Health Smart Homes and wearable health sensors and he created and directed his own research group at laboratory TIMC in Faculty of Medicine Grenoble (1998-2008). In 2008 he moved to University of Lyon, where he took various responsibilities - Director of the Department of Biomedical Engineering at Polytech'Lyon School of Engineering, Director of the Master in Regulations of Medical devices, Director of the BSc in Medical Technologies at IUT Lyon 1. Since 2008, he was also with the Biomedical Sensors research group at INL-INSA Lyon where he launched a Living Lab for Health and developed several innovative wearable non-invasive smart sensors for continuous monitoring of humans (actimetrics, fall detection, thermal measurement, non-invasive blood pressure). He is also an entrepreneur who contributed to launching 2 Start Up, exploiting his works and (15) patents. He guided 21 PhD students, authored or co-authored more than 250 scientific papers (H-index 38). He is an expert and reviewer at the European Commission, ESF, CRSNG. He is an active member of the French Chapter IEEE EMBS (President 2015-19, secretary 2013-15, VP since 2019). He was one of the founders of the “Groupement National de Recherche Biomédicale” GDR STIC-Santé in which he led the “wearable health sensors” group (2002-14). He also is frequently involved in the organization committees of international scientific events (General Chair IEEEHealthcom2010 in Lyon and IEEE-Healthcom2018 in Ostrava, local organizing committee IEEE-EMBC2007 in Lyon, pHealth2011 in Lyon, member of the steering Committee of the IEEEHealthcom conference from 2010 to 2020).
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SCOPE
The new European regulation (EU MDR 2017/745) will enter into force on May 26, 2021. This new regulation sets forth new, improved rules to strengthen clinical evidence, particularly for high-risk medical devices for which a clinical study is mandatory. Given the wide range of medical devices available on the market and their countless variations in design features, treatment goals and targeted patient groups, setting a single standard study protocol seems unfeasible.This special session will cover efforts to build clinical evidence in accordance with the new regulations. We accept submissions covering all phases of the development cycle of a new medical device, from preliminary study confirming proof of concept to post-market clinical follow-up (real-world data) as well as in silico trials, first survey clinical in humans, medico-economy or usability study.
TOPICS OF INTEREST
Topics of interest include, but are not limited to:
- Co-Design with End-Users
- Human Factor Engineering
- High Risk Medical Device
- Clinical Investigation on Medical Device
IMPORTANT DATES
Paper Submission:
November 26, 2020 (expired)
Authors Notification:
December 14, 2020 (expired)
Camera Ready and Registration:
December 22, 2020 (expired)
SPECIAL SESSION PROGRAM COMMITTEE
Regis Beuscart,
University of Lille, France
Thierry Chevallier,
BESPIM, CHU NImes, France
Bruno Wacogne,
MN2S, FEMTO-ST, UMR CNRS 6174, France
(list not yet complete)
PAPER SUBMISSION
Prospective authors are invited to submit papers in any of the topics listed above.
Instructions for preparing the manuscript (in Word and Latex formats) are available at: Paper Templates
Please also check the Guidelines.
Papers must be submitted electronically via the web-based submission system using the appropriated button on this page.
PUBLICATIONS
After thorough reviewing by the special session program committee, all accepted papers will be published in a special section of the conference proceedings book - under an ISBN reference and on digital support - and submitted for indexation by SCOPUS, Google Scholar, DBLP, Semantic Scholar, Microsoft Academic, EI and Web of Science / Conference Proceedings Citation Index.
SCITEPRESS is a member of CrossRef (http://www.crossref.org/) and every paper is given a DOI (Digital Object Identifier).
All papers presented at the conference venue will be available at the SCITEPRESS Digital Library