PREPARATION OF TECHNICAL AND OPERATIONAL DOCUMENTATION
Medalis provides assistance in the preparation/refinement of technical documentation and operational
documentation for the registration of a medical device.
High-quality technical and operational
documentation prepared in compliance
with applicable regulations is the most important source of information about a medical
The service is essential for manufacturing companies that obtain registration for
their medical devices independently but lack experience
in preparing certain documents.
Unfortunately, errors in documents submitted to the
registering authority (the Federal Service for Surveillance of Healthcare) result in a large number
of refusals and cost a huge amount of money
and time. Therefore, our job is to prepare a document of the highest standards, compliant with all
applicable regulatory requirements.
OUR SERVICES FOR PREPARATION OF TECHNICAL AND OPERATIONAL DOCUMENTATION
Preparation/refinement/adjustment of technical documentation for the process of state
registration of a medical device (an extract from the technical file; technical specifications);
Preparation/refinement/adjustment of operational documentation for the process of state
registration of a medical device (an operation manual; directions for use);
Preparation/refinement/adjustment of a risk management file for a medical device (a risk
assessment analysis for the risk of use of a medical device at each stage of its life cycle);
Preparation/refinement/adjustment of reports required for the registration of a medical device;
Preparation of information and clarification letters required for the registration of a medical
Refinement/adjustment of documentation in case of refusal to register a medical device where the
submission was initially made by the client or a third-party contractor.