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

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