Medical Devices submitted for utilization on the territory of the Russian Federation are subject to a government registrational review process on the basis of technical, toxicological and clinical trials results to confirm their quality, effectiveness and safety.
Clinical trials for medical devices are specially designed and planned systematic studies that are conducted on human subjects in specialized, licensed investigative sites.
At the present time, clinical studies on medical devices in Russia are conducted under international standards of ICH-GCP and ISO 14155:2011 in the absence of relevant national regulatory standards.
An international contract research organization (CRO), AmeRuss Clinical Trials, LLC has a long and successful experience in conduction Clinical Trials on Medical Devices.
AmeRuss provides high level, comprehensive support for the conduct of all phases and types of clinical trials for medical devices including protocol creation, study design selection and optimization and other full-cycle clinical services.
AmeRuss’s strategic advantage derives from its alliance with ZAO SHAG and ZAO Implanta, the largest distributors of medical devices in the region. Due to this long-term, reliable business association, AmeRuss has an extensive professional network in Russia and the CIS that garners numerous investigative sites of Russian Academy of Science (RAS), the Ministries of Health and related sanctioning organizations involved in the conduction of clinical trials on medical devices.