Certification Centre of Medical Equipment VNIIMP is one of the leaders among organizations which carry out certification of domestically produced and imported medical devices in Russia. Limited liability company “CCME VNIIMP” Certification Body and Test Laboratory are accredited by GOSSTANDART of Russia (now as Federal Agency on Technical Regulating and Metrology) in certification of a wide range of medical products. The staff of our company consists of highly qualified specialists. Most of our fellows have had over twenty years’ experience of working in the field of standardization, metrology, certification and testing medical products.
We are glad to offer you our services:
- certification and declaring of domestically produced and imported medical devices in GOST R system;
- certification tests of domestically produced and imported medical devices;
- drawing up customs letters for the purpose to carry out customs clearance of medical devices, imported into the territory of the Russian Federation with the purpose of registration in the Ministry of Health (now as Federal Service for Surveillance in the Sphere of Healthcare and Social Development (Roszdravnadzor));
- help foreign manufacturers in getting a certificate of registration;
- certification of quality management systems in accordance with GOST R ISO 9001-2000, GOST R ISO 13485-2004 in Russian companies, that produced medical devices;
- consultancy in the field of the establishment and implementation of a quality management system in an organization;
- assistance in conducting certification of medical devices in accordance with the requirements of the European Directives (the CE-marking) and quality management systems in accordance with ISO 9001:2000 (GOST R ISO 9001-2001), ISO 13485:2003 (GOST R ISO 13485-2004).
Certification Centre of Medical Equipment VNIIMP
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