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.