Medical devices
Objectives of the group
- Participate in the reflection on the evolution of clinical evaluation methods for medical devices
- Defend the attractiveness of the French territory in terms of clinical evaluation of medical devices.
- Contribute to consultations with the authorities on the evolution of the regulatory provisions concerning the evaluation of the Medical Device
How it works :
Created in 2007, it currently has a dozen members who meet every month.
Actions :
- Meet and exchange with players in the world of medical devices (manufacturers, representative bodies, health authorities, etc.).
- Inform medical device manufacturers of the CROs’ job and their added value in clinical evaluation
- Organize and participate in events on the theme of clinical evaluation, its regulation and implementation in order to help manufacturers meet their obligations. The group organises the annual AFCROs & Medical Device Meetings and participates in the AFCROs Clinical Research Day with workshops dedicated to MD.
- Publish articles dealing with clinical evaluation in the medical device trade press.
Group Members
- Aline ABRAVANEL | GENACTIS
- Patrick BLANDIN | TELEMEDICINE TECHNOLOGIES SAS
- Sandrine BOURGUIGNON | IQVIA
- Odile CAPRONNIER | EURAXI PHARMA
- Morgane CHAMPIOT | RCTS
- Christophe CLEMENT | ICTA PM
- Sandrine COLAS | IQVIA
- Estelle GEFFARD-DUCHAMP | ICON
- Christophe GRENOT | 4CLINICS
- Fabien LECLERCQ | EVAMED – Animateur
- Rafik NAMANE | AXELYS SANTE
- Sara SOHIER | POPSICUBE-FOVEA
- Christophe SOYEZ | MEDI LINK
- Nadia ZENASLI | VIGIPHARM
Contact : groupe-dm@afcros.com
Find their articles published in DeviceMed magazine:
NEW: MDR: a manufacturer’s perspective on clinical data collection – Read article
sept-october – Risk-based-monitoring: a solution adapted to medical devices by Odile Capronnier
July-August – The medico-economic evaluation of MDs: state of play and issues by Sandrine Bourguigon
May-June – How to match clinical data with SNDS data? by Lucie de Léotoing and Patrick Blandin
March-April – The investigating physician: a key player, but not alone… by Christophe Soyez and Patrick Blandin
January-February – The new Health Data Hosting certification process by Sara Sohier
Articles 2018 :
- Class III DM: easier to market in the USA than in Europe ?
- 2008-20018 : Clinical evaluation is finally becoming a matter of course!
- What type of clinical study should be carried out and for what result? (September-October 2018)
- The DPO: an asset to comply with the RGPD (July-August 2018)
- Real Life Health Data (RLHD): Useful for the development of MDs (May-June 2018)
- The contribution of CROs to the clinical evaluation of medical devices (March-April 2018)
- The health economist: between clinical effectiveness and economic issues (January-February 2018)
Attractiveness
Acting with and with all stakeholders to make France an attractive country for Clinical Research
Medical devices
French expertise on the clinical evaluation of medical devices
Clinical Research Professions
Promote clinical research careers among students and professionals
Real world data
French expertise on real life primary and secondary data
AI & Clinical Research
Use of Artificial Intelligence to serve our CRO professions
Patients and Clinical Research
Patients at the heart of clinical research
Regulatory
single convention
Monitor the use of the single convention
Regulatory
CPP-ANSM
Follow the regulations relating to study authorization requests
Regulatory
CNIL-RGPD
Follow health data protection regulations
Human vigilance
To develop and share good practices for the professional achievement of Clinical Research staff
Decentralised clinical trials
Reflections on the creation of an agile and secure methodology for the development of decentralised clinical trials in France.