CE Mark Clinical Strategy

Our clinical experts support you on:

  • The clinical regulatory strategy of your medical devices;
  • Support for answers, arguments and clinical exchanges with Notified Bodies;
  • The design of clinical studies including clinical investigations, with drafting of constitutive documents;
  • Obtaining the relevant regulatory authorizations (from the ethics committee or competent authorities such as CPP, ANSM, CNIL). This stage includes the submission of the file, the obtaining of admissibility, the answers to the questions until obtaining the necessary favorable opinions and authorizations.

More activities on Scientific and clinical writing

For all health products

Medical Devices (DM)

  • Single-use, implantable, capital equipment, etc
  • Therapeutic, Diagnostic or prognostic

In vitro diagnostic devices

  • Biological procedure acts
  • Companion tests
  • Capital equipment and consumables

And other innovative technologies

  • Connected medical devices or tele surveillance activities
  • Foods for special medical purposes