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Additional Services

  • Preparation of the documents to obtain Import Permission for medical devices.
  • Organization of engineers and doctors departures for the purpose of field trials.
  • Definition of MD’s normative documents and preparation of data on normative documentation for MD.
  • Preparation of technical documentation, correction of operational documentation, development of technical conditions (TC), notifications of changes in technical conditions, completion of TC notifications.
  • Amendments in a Registration Certificate
  • Amendments in a registration dossier
  • Obtaining Duplicate of Registration Certificate
  • Change of a Registration Certificate’s Blank
  • Conducting technical, toxicological, EMC, as well as SIMN tests
  • Conducting clinical trials in the form of analysis and evaluation of a clinical data
  • Selection of interchangeable medical devices, preparation of protocol of the technical characteristics comparison
  • Preparation of requests to authorized bodies