Preparation of technical and operational documentation

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 device.
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 device;
• 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.