ООО Resultat audit LLC is a consulting company offering registration of medical devices both in the Russian Federation and the EAEU on a turnkey basis. It prepares technical and operational documentation in accordance with the regulatory requirements, decrees of the Government of the Russian Federation, orders of the Ministry of Health of the Russian Federation, the Federal Service for Surveillance in Healthcare (Roszdravnadzor), and decisions of the Eurasian Economic Commission (EEC). The turnkey registration service involves preparing technical and operational documentation; managing interactions with our own testing laboratories (comprised in Electrontest companies Group); monitoring tests and providing samples of medical devices; organizing clinical trials and clinical laboratory testing of in vitro products; compiling registration dossiers; and providing support during the registration process at Roszdravnadzor.

The company has a vast experience obtaining registration of medical devices from Roszdravnadzor. In the period between 2012 and 2022, more than 550 Registration Certificates for various types of medical devices, including more than 60 Certificates for in vitro products were obtained.

Resultat audit LLC runs a Training Center that is licensed to provide additional educational services and offers skills upgrading programs for specialists in registration of medical devices.

Electrontest LLC runs the Testing Center which includes the Technical Device Safety Testing Laboratory of Electrontest LLC accredited by the Federal Accreditation Service (Rosakkreditatsiya) to carry out technical tests of medical devices, and the Clinical Diagnostic Laboratory of Electrontest LLC which holds a license for clinical diagnostic tests from Roszdravnadzor and is accredited in the EAEU to conduct clinical and laboratory testing of in vitro medical devices for the purposes of their registration. To conduct its clinical trials and clinical diagnostic tests, Electrontest Clinical Diagnostic Laboratory closely cooperates with various clinics in Moscow (such as the Municipal Clinical Hospital No. 67 named after L. A. Vorokhobov, the Laboratory of the National Agency for Clinical Pharmacology and Pharmacy (NAKFF), the National Research Center for Epidemiology and Microbiology named after N. F. Gamaleya, the Central Research Institute of Epidemiology under Rospotrebnadzor, the National Medical Research Center of Oncology named after N. N. Blokhin, the National Medical Research Center of Oncology named after N. N. Petrov, Next-Bio LLC (a biotechnology company), and a number of other research and medical treatment facilities.

The Testing Center of Electrontest LLC was accredited by the ILAC European system, and thus can accept test reports (including for in vitro devices) to obtain European CE product safety certification.

The Center for Technical Safety of Materials, Equipment and Complex Systems (CTB MOS LLC) - is a manufacturing company that designs and manufactures test equipment for technical testing of various types of products, including medical devices and products relating to all technical regulations of the Customs Union. Over a short period of time, the company has grown from a small operation manufacturing testing equipment for its in-house testing laboratories into a high-tech production facility with its own design bureau, metrology unit, maintenance department and production facilities outfitted with modern equipment. The company has received certification of its production compliance with ISO 9001 from TÜV Austria. All the development activities of the company are based on the automation of the testing process. To achieve this, the equipment it manufactures is provided with tools for data collection and control of test equipment and is integrated into the Internet and, ultimately, into the Laboratory Information System (LIS) of the testing centers.

The company has launched a new business line — production of microelectronics (measuring instruments, programmable relays, programmable logic controllers, programmable touch controllers and other specialized devices). We cooperate with ARTEX to develop software to control our microcontrollers and integrate them into exiting software platforms for process control.