Clinical trials of medical devices
Comprehensive service for organizing, conducting and obtaining the results of clinical trials of medical devices
Consultation, inspection of documents, selection of medical and preventive treatment institution, development of a program for clinical trials
An initial analysis of information on the medical device and its documentation shall be conducted. A schedule of tests and studies shall be drawn up, and if necessary, the development of documentation required for the Marketing Authorization File shall be included. The procedure for clinical trials of medical devices is regulated by the Order of the Ministry of Health of the Russian Federation of January 9, 2014 No. 2n «On Approval of the Procedure for Assessing the Conformity of Medical Devices in the Form of Technical Tests, Toxicological Studies, Clinical Trials for the Purpose of State Registration of Medical Devices»
Transmission of MD to the medical institution
A medical device with a set of accompanying documentation shall be transmitted to a medical institution for clinical trials
Monitoring of the testing process of medical devices
The company’s specialists carefully monitor the timing and quality of the tests
Examination of the results, preparation of the set of documents
Work via Personal Account allows for establishing a connection between the developer, manufacturer and production sites. Our specialists pay a particular attention to ensure that the quality, performance and safety of MD is documented. Our knowledge and experience allow us to pass the examination in the subordinate institutions of Roszdravnadzor without objections
Submission to Roszdravnadzor
We strictly adhere to the schedule and the Rules of state registration of medical devices. Documentation undergoes a multi-stage control system.
The process is structured so that you do not have to spend significant financial and time resources for the registration. You have a round-the-clock access to the up-to-date information on the work progress via your Personal Account on our website.