medical device testing laboratories
The procedure to conduct testing on medical devices establishes the order of the Ministry of Health of the Russian Federation of January 9, 2014. N 2N "On approval of the procedure for evaluating the compliance of medical products in the form of technical testing, toxicological research, clinical trials in order to state registration of medical devices"
Unlike most countries, Russian Fedearation and EAEU still relie on product testing in granting approval for medical devices, and this testing must be completed by local loboratories regardless of whether the device already has US 510(k) clearance or European CE Marking.
Sertigrad" offers a wide range of support services for laboratory testing products and medical devices. In order to Conduct laboratory
testing products and medical devices during certification, the applicant ( manufacturer) must provide documents with which our
specialists will clearly identify the products and develop a plan for the lab testing your devices;Technical specification;User Manual;
Previously issued certificates, declarations and test reports and other documents depending on the output of the products,the results
of the tests carried out are drawn up in the test report with the signature of the testing laboratory.
Testing of imported products The Center for obtaining permits "Certigrad" helps in passing Tests of imported products.According to
(Decision of the EEC Board No. 293 of December 25, 2012; Federal Law No. 184-FZ of December 27, 2002), all goods, products, equipment
that are delivered to the territory of the Eurasian Economic Union must be tested in an accredited laboratory.after testing of
imported products, the customer receives a test report.
On the basis of a positive laboratory testing report, it is possible to issue the certification or declaration procedure for the
subsequent import of products into the territory of the Eurasian Economic Union.
Medical device testing laboratories
The company "Sertigrad" organizes technical, toxicological and clinical studies (labt ests) according to the rules of the Eurasian
Economic Union and the national procedure of the Russian Federation.We will help you find accredited Testing Laboratories in
accordance with the regulatory requirements of Rosaccreditation for your products.
what we will do for you
a)Agree on the testing program;
(b)To solve problems with laboratories;
(c)To get the protocols of drinking.
You can apply for the service using the form on the main page of our website or contact our managers.