Specific Expertise Medical Device

/Specific Expertise Medical Device
Specific Expertise Medical Device Emmanuel Sanchez 2018-04-14T11:07:17+00:00

SPECIFIC EXPERTISE MEDICAL DEVICE

As early as 2001, ITEC Services conducts clinical investigations for Medical Devices and Health Technologies field industries by adapting methodology to the product type.

In this field, we develop “tailored” models that respond to product types, to technical characteristics of performance and sometimes multifactorial risks, to offer a clinical study only when it is necessary.

ITEC Services business is to support a manufacturer to demonstrate the safety of his product, and the clinical benefit for the patient.

  • Clinical investigations for market authorization and Pricing / Reimbursement strategy
    • Pilot study “First in man” : efficacy and safety
    • Randomized comparative evaluation of :
      • Efficacy and safety for the HAS requirements.
      • Cost-effectiveness for the CNEDiMTS requirements.
  • Post-Market Surveillance Activities: Retrospective / Prospective studies
    • To collect all tracking data of products placed on the market
      • To have a market access (CE certification)
      • Obtention du remboursement et/ou évolution du prix.
  • Studies including or dedicated to improvement evaluation of patient’s quality of life
    • ePro solution : collecting data directly from the patient