Resultat-Audit LLC has been supporting medical device registration in Russia and the EAEU for more than 18 years. We work with manufacturers and suppliers of medical technology, guiding them from the initial product assessment and preparation of documentation through issuance of the Registration Certificate and entry of the relevant information in the register.
We specialize in medical device registration, preparation of registration dossiers, development of technical and operating documentation, organization of testing, and management of interactions with expert organizations and Roszdravnadzor.
Over the years, our team has completed more than 800 projects, including registration of complex medical equipment and in vitro diagnostic devices. We understand not only the formal legal requirements but also the practical side of the procedure: which documents are required, where deficiencies most often arise, and how to reduce the risk of refusal or delays in advance.
We specialize in medical device registration, preparation of registration dossiers, development of technical and operating documentation, organization of testing, and management of interactions with expert organizations and Roszdravnadzor.
Over the years, our team has completed more than 800 projects, including registration of complex medical equipment and in vitro diagnostic devices. We understand not only the formal legal requirements but also the practical side of the procedure: which documents are required, where deficiencies most often arise, and how to reduce the risk of refusal or delays in advance.
A key advantage of our company is our integrated approach. The Group includes its own testing laboratories, allowing us to organize technical, toxicological, electromagnetic and other required testing without a gap between document preparation and the practical stages of the registration procedure.
We support projects in the format most convenient for the client: we can manage registration on a turnkey basis or join at individual stages, including development of Technical Specifications, preparation of operating documentation, dossier compilation, organization of testing, analysis of regulator comments and revision of materials.
We support projects in the format most convenient for the client: we can manage registration on a turnkey basis or join at individual stages, including development of Technical Specifications, preparation of operating documentation, dossier compilation, organization of testing, analysis of regulator comments and revision of materials.
Our goal is not simply to prepare a set of documents, but to guide a medical device through the registration procedure in a consistent and legally compliant manner, taking into account current Russian Federation and EAEU requirements, through issuance of the Registration Certificate.
Resultat-Audit LLC is part of the Electrontest Group and provides an integrated solution for medical device registration in the Russian Federation and the EAEU. In addition to Resultat-Audit LLC, the Group includes the following companies:
Our advantages
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Deep expertise in medical device registrationWe work with medical devices of all risk classes, from simple products to high-risk ones. Our approach reflects Roszdravnadzor's current requirements and how expert reviews actually go in practice, which reduces the risk of comments and requests for revisions. -
In-house resting laboratoriesWe carry out technical, toxicological and EMC testing in our own facilities. This lets us avoid third-party organizations, shorten timelines and keep full control over the quality of results. -
End-to-end registration managementWe handle the development and revision of documentation, and we prepare and manage the registration dossier. We support the project through every stage of the expert review and, when needed, help introduce amendments to the registration certificate.
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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