medical market access, what MERC offers you.

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Medical Market Access by Merc

Merc will deal with all the strategy path for the market access in the easiest/fastest way.

  • 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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