REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot177310.32687/1561-5936-2024-28-3-208-213Original ArticleComparative analysis of standards in the field of quality management system at all stages of the life cycle of medical devicesGertsikYury G.ygerzik@bmstu.ruRoschinDenis O.droshchin2@gmail.comAksenovaAnastasia M.003Bauman Moscow State Technical University, Moscow, RussiaN. A. Semashko National Research Institute of Public Health, Moscow, Russian Federation15122024320821316102025Copyright © 2024,2024The global production of medical devices is growing and developing every year, the situation in the medical industry of the Russian Federation is no exception. In this regard, in order to maintain the competitiveness of Russian manufacturers not only in the domestic, but also in the world markets, it is necessary to comply with international standards of product quality: for this purpose, in recent years, a unified quality system has been actively introduced in the region of the Eurasian Economic Union, based on Western standards of the International Organization for Standardization, in particular 9001 and 9004. No less important is the fact that it is necessary to harmonize the internal quality systems of industrial enterprises and quality systems for the operation of medical equipment that exist in medical institutions to create a single information space for the safety and efficiency of operation and after-sales service.quality management systemmedical industrymedical equipmentstandards of the International Organization for Standardizationmedical institutionsenterprises of the medical industryсистема менеджмента качествамедицинская промышленностьмедицинское оборудованиестандарты Международной организации по стандартизациилечебно-профилактические учрежденияпредприятия медицинской промышленности1.Aksenova A. M., Gertsik Yu. G. Analysis of quality control mechanisms in the field of production and maintenance of medical devices. Charnovsky Readings. XII All-Russian Scientific Conference on the Organization of Production: a Collection of Works. Moscow; 2022. P. 5–11. (In Russian)2.Dyukov A. B. The future of E-health lies in the standardization and unification of data. Menedzhment kachestva v meditsine. 2023;(1):53–56.3.Gertsik Yu. G. Aksenova A. M. Implementation of quality management systems based on ISO standards within the framework of the single market for the circulation of medical products of the EAEU countries. Ekonomika Tsentralnoy Azii. 2023;8(1):29–52. (In Russian)4.Astapenko E. M., Sukhanova M. M. Rules for registration and examination of safety, quality and effectiveness of medical devices within the framework of the Eurasian Economic Union. Vestnik Roszdravnadzora. 2016;(5):17–20. (In Russian)5.Gertsik Yu. G., Plutnitskiy A. N., Roshchin D. O. Issues of regulation of handling of medical products in the markets of the Eurasian Economic Union. Manager Zdravoohranenia. 2020;(7):60–64. (In Russian). DOI: 10.37690/1811-0185-2020-7-60-646.Kurakova N. G. Service contract for the maintenance of medical equipment — new opportunities for healthcare facilities. Manager Zdravoohranenia. 2011;(12):49–55. (In Russian)7.Gertsik Yu. G. The new model for improving quality of service: entering into life-cycle contracts for the purchase and maintenance of medical devices. Manager Zdravoohranenia. 2020;(5):54–59. (In Russian)8.Rudenko M. N., Okulova O. V. Analysis of the Russian medical device market in order to develop an effective business model and market entry strategy. Moscow Economic Journal. 2020;(10):411–420. (In Russian). DOI: 10.24411/2413-046X-2020-10671