MEDEXPERT is a consulting company. Since 2001, we have been helping Russian and foreign medical product manufacturers to obtain Certificates of Registration for medical products. During this time, we helped manufacturers register 950 medical devices, amend 1.6 thousand Registration Dossiers, issue 3.5 thousand Certificates of Conformity, 7 thousand Declarations of Conformity, 1.3 thousand Letters of Exemption. Our Company has 2.5 thousand clients.
We make the product registration process simple for the manufacturer and his authorized representative. Over 20 years we have tried many methods for preparing a Registration Dossier. We know which ones are better for some products, which ones are better for others. We use an up-to-date base of standards when preparing Technical Documentation. We understand how to build a registration process in order to obtain a Certificate of Registration for your product in reasonable amount of time.
MEDEXPERT was founded by one of the first three consulting companies in Russia to help manufacturers of medical products.
MEDEXPERT is one of the founders of the LUSOMI Association, the purpose of which is to unite participants in the circulation of medical products for the development of a civilized market and the formation of a modern infrastructure for the circulation of medical products. The Association's inquiries allow receiving clarifications from various authorities on complex issues of the circulation of medical devices.
We helped prepare three technical laboratories for accreditation and one toxicology laboratory; we participated in the preparation of documents for the inclusion of two clinics in the list of the Federal Service for Supervision in Healthcare organizations admitted to clinical trials.
MEDEXPERT was the first in Russia that came to include Technical Test Reports containing electrical safety and electromagnetic compatibility tests for electrical products in the Registration Dossier. This has helped to improve the quality of the safety checks for electrical medical devices during the pre-registration phase.
OUR SCOPE OF SERVICES
MEDEXPERT provides comprehensive services for obtaining Certificates of Registration for medical products of Russian and foreign production in Russia and the EAEU: from coordinating the layout of the future Certificates of Registration to obtaining the original document. We will also help with a separate service of your choice. A detailed list of our services is given on the main page of the website in the Services section.
We work with endoscopic, dental, ophthalmological, traumatological, physiotherapeutic, orthopedic, surgical, rehabilitation, cardiovascular, gastroenterological, urological, gynecological, otolaryngological, auxiliary and general hospital medical products, products for anesthesia and resuscitation. Our experience also includes successful registration of in vitro diagnostic devices.
We take personal charge of communication with a foreign manufacturer, development of documents, filling out all forms so that entrepreneurs can focus on business. We will collect the necessary information, develop any documents, including technical, operational ones, risk management file as well as will form a Registration Dossier. We organize toxicological tests, tests for sterility, tests for implantation, clinical as well as technical tests, including measuring-instrument testings, functional tests, electrical safety and electromagnetic compatibility tests.
Toxicological and technical tests are carried out in Centers accredited by the Federal Service for Accreditation. Clinical trials are carried out in medical organizations that are approved by the Federal Service for Supervision in Healthcare for testing. The organizations we cooperate with have at least 10 years of experience in medical device testing.
We also prepare documents for licensing of the medical product manufacturing. We put together dossier for registration of a license for medical device maintenance. We help to pass the manufacturing inspection during the licensing process. We participate in the training of specialists, in the issuance of an ISO 13485 Certificate for production and maintenance licensing. We will provide assistance in checking production and in the registration process under the new rules of the EAEU.
The Medexpert Group includes Medexpert LLC with an office at Rustaveli Street in Saint Petersburg and Medexpert Consulting LLC located at Myasnitskaya Street in Moscow.
We have created a team that is able to bring complex projects to a positive result - obtaining a Certificate of Registration
Employees of the company undergo training annually at the seminars of the Federal State Budgetary Institution All-Russian Research and Testing Institute of Medical Technology and the Federal State Budgetary Institution National Quality Institute of the Federal Service for Supervision in Healthcare in order to be aware of the latest changes in legislation.
The purpose of our work is to make the issuance of medical device permits simple for the manufacturer.
Save the https://medexpert.ru/en/ website to bookmarks. As long as you have it in your list of favorites, there is a chance to register a medical product. If you have new medical products, it will be easier and faster to obtain Certificates of Registration for them with our assistance.