PREPARATION OF TECHNICAL AND OPERATIONAL DOCUMENTATION
We provide independent assistance in the preparation/refinement of technical documentation and operational documentation for the purposes of further 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.
This service is essential for manufacturing companies that are planning to obtain registration for their medical devices on their own but lacking experience in preparing certain documents.
Unfortunately, errors in documents submitted to the Registering Authority (Roszdravnadzor) result in a large number of refusals to register medical devices and require huge amounts both of money and time. Therefore, our job is to prepare a document to the highest standards and in compliance with all applicable regulatory requirements.
OUR SERVICES FOR THE PREPARATION OF TECHNICAL AND OPERATIONAL DOCUMENTATION
- Preparation/refinement/adjustment of technical documentation for the purposes of state registration of a medical device (an extract from the technical file; technical specifications);
- Preparation/refinement/adjustment of operational documentation for the purposes of state registration of a medical device (an operation manual; instructions 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 purposes of registration of a medical device;
- Preparation of information and clarification letters required for the purposes of registration of a medical device;
- Refinement/adjustment of documentation in case of refusal of registration of a medical device where the submission was initially made by the client or a third party contractor.