Development Strategy

ELECTRONTEST Companies Group started as a laboratory for testing medical devices. The expansion of the regulatory and legal framework for the purposes of control over the circulation of medical devices in the Russian Federation and subsequently in the Eurasian Economic Union (EAEU) has driven its development and the establishment of new companies. This, in turn, required building a team of highly skilled professionals in the field of preparation of technical and technical documentation for medical devices in accordance with regulatory requirements and increasing our fleet of testing equipment and measuring instruments to support a wide range of methods for testing medical devices.

In order to be able to improve procedures for registration of medical devices, carry out post-marketing monitoring and, accordingly, meet tighter requirements for the quality and safety of medical devices, we had to expand ELECTRONTEST Companies Group by establishing specialist companies focused on compiling marketing authorization files and conducting technical and toxicological tests.

The need for conducting technical testing and clinical trials of in vitro products to assess their conformity and verify the analytical and diagnostic performance claims for medical devices in the course of their registration in Russia and the EAEU motivated us to establish a clinical diagnostic laboratory (CDL) at the Testing Center of Electrontest LLC.

Testing and assessing analytical and clinical efficacy of in vitro products (especially during the COVID-19 pandemic) have led to the creation of a database of control materials and standard samples from different suppliers with validation reports and metrological traceability to the applicable standards. This, in turn, demanded the CDL staff to be highly skilled and knowledgeable in operation of a wide range of medical devices, from ordinary dipsticks to genetic test systems.

By creating and upgrading its testing lab facilities, ELECTRONTEST Companies Group has completed a large amount of fixed assets construction to provide rooms for its laboratories and has equipped its special-purpose spaces with a separate supply and exhaust ventilation system to create appropriate climatic conditions for testing.

By setting up in-house production of high-tech testing equipment at the facilities of the Center for Technical Safety of Materials, Equipment and Complex Systems (CTB MOS LLC), we were able to supply ELECTRONTEST Companies Group testing laboratories with unique test benches, thereby significantly expanding our testing capabilities for a wide range of medical devices. The development of the production facilities has extended the range of testing equipment being manufactured. At present, CTB MOS LLC manufactures specialty test equipment for nearly all technical regulations. We have developed and implemented an ISO 9001 Quality Management System, which forms the basis for the development of our production. CTB MOS LLC has been certified as compliant with ISO 9001 by TÜV Austria, an accredited Austria-based body for certification of quality management systems. The company has developed a new business line involving the design and manufacturing of programmable controllers and specialized measuring instruments for the automation of the testing process for various product types.

ELECTRONTEST Companies Group is constantly engaged in research and development of new testing methods, testing process design, development of new types of test equipment, new types of programmable controllers, measuring instruments and specialist software. Staff members of ELECTRONTEST Companies Group regularly have their papers on enhancing the performance of testing laboratories published in specialized journals.

At the moment, all operations of ELECTRONTEST Companies Group are focused on services for registration of medical devices in the EAEU. In pursuance of this goal, ELECTRONTEST Companies Group is establishing representative offices in the Republic of Kazakhstan and the Republic of Belarus

We consider the need to bring together the capabilities of national testing centers and independent testing laboratories accredited in both national and in EAEU accreditation systems as ISO 17025 compliant as the key focus area in our business of testing medical devices for the purposes of their registration in the EAEU in order to be able to provide the most comprehensive assessment of the conformity of medical devices throughout the EAEU. For this purpose, we negotiate and cooperate with the main testing centers under subcontracts to manage testing activities in order to provide an end-to-end assessment of the conformity of medical devices to national and international standards and manufacturers’ technical and operational documentation. This is exemplified by the agreements for cooperation in testing that the testing laboratories of Electrontest LLC and ElectrontestBio LLC have with the Russian National Institute for Research, Development and Testing of Medical Equipment (Federal State Budgetary Institution).

We have always been open for cooperation with all players on the medical device market both in the Russian Federation and in the EAEU countries. We are willing to discuss cooperation with any companies and organizations to ensure safety and verify the quality and efficacy of medical devices.