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.
- 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.
4CLINICS – Grenot GRENOT
AXELYS SANTE – Rafik NAMANE
AXONAL-BIOSTATEM – Jean-Pierre MEUNIER
AXONAL-BIOSTATEM – Alice SANCHEZ-PONTON
EURAXI PHARMA – Odile CAPRONNIER
EVAMED – Fabien LECLERCQ – Host
GENACTIS – Aline ABRAVANEL
ICTA PM – Christophe CLEMENT
IQVIA – Sandrine COLAS
IQVIA – Sandrine Bourguignon
MEDI LINK – Christophe SOYEZ
MEDPASS International – Sarah SORREL
POPSICUBE-FOVEA – Sara SOHIER
RCTS – Morgane CHAMPIOT
TELEMEDICINE TECHNOLOGIES SAS – Patrick BLANDIN
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)