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Special Session
Special Session on
Dealing with the Change in European Regulations for Medical Devices
 - ClinMed 2022

9 - 11 February, 2022

Within the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - BIOSTEC 2022


CO-CHAIRS

Lionel Pazart
Tech4Health/F-CRIN
France

 
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.
Norbert Noury
University of Lyon
France

 
Brief Bio
Norbert Noury is a Full Professor covering Electronics and Physics in Medical devices and researcher in Biomedical Sensors team at INL-INSA Lyon where he developed activities in the fields of eHealth, connected health sensors, ambient assistive living environments. He is currently Director of the Master in Regulations of Medical devices at Polytech'Lyon School of Engineering, Director of the BSc in Medical Technologies at IUT University Lyon 1. He also launched a Living Lab for Health and developed Wearable non-invasive Smart Sensors for continuous monitoring of actimetrics, fall detection, thermal measurement, blood pressure. He is also an entrepreneur who contributed to launching 2 Start Ups, exploiting his work and (15) patents. He guided 20 PhD students, authored or co-authored more than 200 scientific papers (h index 36), and is a recognized expert at the European Commission. He is also frequently involved in the organization committees of international scientific events.

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, 2021
Authors Notification: December 14, 2021
Camera Ready and Registration: December 22, 2021

SPECIAL SESSION PROGRAM COMMITTEE

Available soon.

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, The DBLP Computer Science Bibliography, Semantic Scholar, Microsoft Academic, Engineering Index (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

SECRETARIAT CONTACTS

BIOSTEC Special Sessions - ClinMed 2022
e-mail: biostec.secretariat@insticc.org
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