— Services — Registration of Medical Devices in Russia and the EAEU — Registration in the Russian Federation

Comprehensive support for the process of obtaining a Registration Certificate (RC) in accordance with national regulations.

Initial inspection, if required

Organizing and optimizing the cost and volume of translations for the required documentation

Preparing the manufacturer’s quality management system for an inspection to verify compliance with implementation and maintenance requirements. Production inspection (if required) and support throughout all stages of the assessment

Arranging logistics and customs clearance for trial samples

Verification of the completeness of the manufacturer’s documentation required for compiling the dossier

Preparation of a registration dossier in accordance with the registration requirements

Organization and management of technical and clinical trials, as well as toxicological studies

Obtain your Registration Certificate in a timely manner.
We help you bring your product to market faster, ensuring a smooth and rapid launch.