MEDICAL DEVICE TESTING

Based at St. Petersburg Bio-Physiological Equipment Research Institute
(Biofizpribor, Russian Certificate # POCC RU. 0001.22ИМ08)
Since 1955 the center was testing devices for Russian medical industry, including space medicine.
 

ACCESS TO RUSSIAN MARKET

By law all medical products, both domestic and foreign, used on the Russian territory are subject to registration by Russian Government regulatory authorities. Our certified testing equipment and highly skilled personnel will perform testing of your product according to the highest standards, which helps to minimize risk both for manufacturers and consumers. We will also prepare documents for the registration to help your product to gain access to Russia.

SERVICES

• Verify that the product characteristics correspond of its technical documentation, as well as the safety and electro-magnetic compatibility;
• Clinical trial in certified hospitals;
• Write regulatory documents and manuals;
• Prepare applications and certificates for registration in the Russian Federal Service of Health and Human Development (FDSHHD);
• Translate and notarize manufacturer's documentation for FDSHHD;
• Represent the manufacturer at FDSHHD;

ADDRESS

Sabirovskaya 37
St. Petersburg, Russia, 197183
phone/fax in Russia: +7 (812) 430-9333
E-mail: biophiz@peterlink.ru

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