Preparation of documents for medical devices registration according to the regulation requirements;
Changes assessment, development of documents and clarifying letters from a manufacturer to execute a dossier update procedure.
Organization and coordination of all required local tests/trials (toxicological, technical, EMS, approving the type of measuring tools, clinical trials).
Documents preparation and support at all stages of licensing procedure.
Our company provides services for medical devices registration for their subsequent admission for circulation in Russian Federation and EAEU countries, as well as services for dossier update, support in medical devices certification, assistance in licensing of medical devices maintenance and production.
We understand the importance of each project and we take a responsible approach to the proposed services execution, ensure compliance with regulations and interpretations of regulatory authorities and provide solutions for varying complexity tasks.
We know what difficulties customers face modifying a product after its registration, so we try to minimize the need for constant registration dossier update and thus ensure its long-term compliance with the delivered product.
Not only timely receipt of the registration certificate is our goal, but also high quality of the submitted dossier.
We do care about our customers and offer the best solutions for each specific case. It is really important for us to maximize benefits for our customer.
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