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State registration of medical devices for Russian and foreign manufacturers.
Carrying out the registration process of medical devices on the territory of the European Union.
Registered dossier amendment (VIRD procedure).Registration certificate amendment (VIRU procedure).
Development and optimization of technical and operational documentation.
State registration of medical devices in the countries of the Eurasian Economic Union: Russian Federation, Kazakhstan, Belarus, Kyrgyzstan, Armenia.
Development and implementation of the quality management system for medical devices ISO 13485 and ISO 9001 with the guarantee of successful certification with international accreditation.
Organization and support of toxicological studies, technical and clinical tests, electromagnetic compatibility (EMC) tests, medical devices type approval tests.
Searching for a Distributor / Authorized representative of the manufacturer in the Russian Federation. Service for foreign manufacturers.
Medical device consultation service.
Preparation of documents for obtaining a duplicate of the registration certificate.
Preparation of documents for replacing the registration certificate.
Service for receiving explanatory letters from Roszdravnadzor.
Audit of documentation.
Preparation of documents for obtaining permission to import samples for registration.
Support for obtaining certificates and declarations of conformity.
Translation of documents and notarization.
MedExpertPro Groupmedical device registration
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