We have extensive knowledge of the medical devices life cycle and market rules due to our professional history in Manufacturing Industries, Distribution, Therapy & Market Development.
Market initiators for new medical devices with competences in:
- Preliminary evaluation of Regulatory strategy path.
- Identification of the best regulatory strategy to reach the market in the easiest/fastest way.
- Proposal of different regulatory strategy with pro and contra for each of them.
- Compile a Technical File with evidence of compliance to the Medical Device Directive (or the IVD/AIMD Directives)
- Submit the technical file to the Notify Body and receive a CE Mark certificate if medium or high risk device
- Appoint an Authorized Representative if you have no physical location in Europe
- Register your medical devices with the Competent Authorities in the different European Countries (Class I, device national notification)
- Develop and Maintain a Post market surveillance System according to the Directive and single nations requirements