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Medical devices

A field with new needs

Medical device manufacturers need to have clinical data to back up their regulatory filings - especially for market access and as soon as the CE mark has been granted.

  • The authorities may require efficacy data that proves the clinical benefit for the patient as part of a reimbursement request – particularly in France.
  • The French authorities often require "real-life" post-marketing studies of device use after the CE mark has been awarded.

Axonal provides medical device manufacturers with project support

Our job is to understand the needs and constraints of a fast-changing, heterogeneous sector with specific characteristics.

We have a high level of expertise in healthcare product evaluation and can support medical device manufacturers from the study design stage through to the production of a report for the healthcare authorities.

We can manage the following projects (in full or in part):

  • upstream studies in which a demonstration of clinical benefit is useful for the CE mark application.
  • the clinical efficacy studies required for reimbursement in France.
  • studies that are funded by the French Ministry of Health’s STIC programme.
  • obligatorily non-interventional, post-marketing studies requested by the French authorities.

Our services range from consultancy (through our holding company Acuitude) and project set-up support through to full-service study design, implementation and management.

We also provide our know-how and our expertise to guide you through the regulatory process.

Our experience

 Axonal is used to fully managing this type of study:

  • with an industrial sponsor.
  • sponsored by one or more learned societies.
  • post-marketing studies of innovative medical devices, when the involvement of several industrial sponsors and learned societies has been requested by the regulatory authorities.


An experienced partner for medical device manufacturers

A CRO with the in-house experience and skills needed to meet the specific requirements of the medical device sector

Clinical studies for reimbursement requests

Post-marketing studies requested by the French authorities