ELMAS Ltd. With over 5 years of experience, we have successfully registered more than 120 medical devices of various types and risk classes from both Russian and foreign manufacturers. Our extensive knowledge of the rules and procedures for state registration of medical devices and pharmaceuticals in Russia and the CIS countries allows us to provide expert guidance to our clients.

At our accredited laboratory, equipped with unique testing equipment that is unmatched in Russia, we conduct electromagnetic compatibility testing of medical devices in accordance with the GOST R IEC 60601-1-2-2014 standard, ensuring the safety of the medical devices during the registration process. Our comprehensive range of services includes document consultation, organization and support of the registration process, preparation of technical documentation, registration within the Eurasian Economic Union, testing of medical devices, and certification according to ISO 13485 standards. We are always ready to assist and look forward to collaborating with you.

Contact us for more information