Writing of clinical documentation

Our expertise covers the drafting of the documents necessary to obtain a CE mark:

  • Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER);
  • Post-Marketing Clinical Follow-up: Plan and Deferral (PMCF);
  • Contribution to PSURs.


We also ensure the drafting of the constituents or supporting elements of these clinical investigations:

  • Synopsis, protocol, information note and patient consent form, investigator brochure and other administrative documents necessary for regulatory submissions;
  • Authorization file from the ethics committee and competent authorities (CPP, ANSM, CNIL);
  • Clinical arguments for these authorities or Notified Bodies.

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