Services

When providing services, we fill out all the forms for You, finalize the documentation for the requirements of the legislation, adjust (if necessary) the technical and operational documentation on the results of testing of medical devices, accompany the entire process from the moment of conclusion of the contract and to obtain the Result.

Information services in the field of admission of medical devices to circulation in Russia
Services for obtaining all necessary documents (registration certificates, certificates, declarations of conformity) for admission to the market of domestic and imported medical products
Assistance in obtaining licenses for production and maintenance of medical equipment
Organization of training of specialists in the production and maintenance of medical devices, apparatus and equipment
Advising the Customer on the composition and preparation of documents
Services of the Authorized representative of the manufacturer on the territory of the Russian Federation (for a foreign manufacturer)
Eliminating observations on the results of the examination of the safety monitoring of medical products
Preliminary examination of documents, preparation of application and its coordination with the Customer
Definition of risk class, okpd2 code and type of medical device
Bringing documents in line with current requirements
Interaction with foreign manufacturers of medical products
Translation and notarization of documents
Selection of analog products
Conducting technical and Toxicological tests in accredited laboratories
Clinical trials (including patients)
Formation of the registration dossier and its submission to Roszdravnadzor
Monitoring the registration certificate process and informing the Customer about the stages of the registration process
Import of medical devices for the purpose of registration