medical devices life cycle and market rules competence


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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