Development of technical documentation

Development of technical documentation is one of the most popular and relevant services provided by KC-PROF. This service is employed by those clients who need help in developing a medical product for further registration and production. In addition to that, this service is relevant for the clients who register a medical device independently but have no experience in developing individual documents which need to be submitted in the registration dossier to the Federal Service for Supervision of Healthcare (Roszdravnadzor). The experts of our company are ready to provide services both for the development of a medical device ‘from the scratch’ (from drafting the input data for design and development to the verification process) and for the development of individual documents required for state registration. We guarantee that the developed documents will comply with all applicable regulatory requirements.

List of Services

  • Development of input data for design and development of medical devices;
  • Development of a risk management file for a medical device (risk analysis);
  • Development of design documentation (drawings, technical specifications, operational documentation, etc.);
  • Drafting of test reports;
  • Verification of the output data;
  • Development of technological documentation (flow charts, validation protocols, technological instructions, etc.).

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