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.