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.
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.