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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

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

Contact :  groupe-dm@afcros.com

Find their articles published in DeviceMed magazine:

NEW: MDR: a manufacturer’s perspective on clinical data collectionRead 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 :

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