The medical-device market is undergoing major changes in medical-device registration procedures.

Continuous changes in regulatory documents and in the procedures for state registration and registration in EAEU countries require manufacturers, their representative offices in the Russian Federation and consulting organizations that prepare documents for Roszdravnadzor registration to adapt to substantially higher documentation and testing requirements. These include large volumes of manufacturer technical and operating documentation, quality-management-system documents and extensive testing to confirm effectiveness, biological safety and compliance with applicable standards.

Our methodological approach to preparing dossiers for submission to Roszdravnadzor is based on regulatory documents governing the preparation and submission of materials for expert review of medical-device quality and safety, methodological guidance issued by expert organizations, and Roszdravnadzor requirements regarding the completeness and quality of submitted documents.

The increased volume of submitted materials and higher requirements for the quality and scope of medical-device testing mean that employees of manufacturing companies responsible for registration need a sound knowledge of regulatory documents, the ability to apply expert-organization requirements in practice, the ability to assess the completeness and quality of testing, and the ability to analyze manufacturers’ technical and operating documentation.

The Resultat-Audit LLC Training Center (educational activity license No. 036176 dated 8 May 2015) provides advanced professional training courses for specialists responsible for organizing medical-device registration processes at manufacturing companies and at consulting companies that provide medical-device registration services.

Companies

Services for obtaining medical device Registration Certificates and preparing medical device documentation. We work in accordance with EAEU rules and Roszdravnadzor requirements.

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