Внедрение системы менеджмента качества на предприятиях медицинской промышленности и оценка ее соответствия требованиям ЕАЭС

Abstract

The paper considers the main aspects and mechanisms of the quality management system implementation at the enterprises of the medical industry, their impact on the safety of circulation of medical devices in the territories of the Eurasian Economic Union member states. Based on the results of the analysis, conclusions are drawn about the applicability and significance of the considered provisions of the quality management system. The aim of the work is to analyze the main provisions of the Federal Law “On Amendments to certain Legislative Acts of the Russian Federation on the circulation of medical devices” draft and the possibilities of their practical application. The draft of the law establishes that the production of medical devices, which are subject to state registration, must meet the requirements for the implementation, maintenance and evaluation of the quality management system of medical devices, depending on the potential risk of their usage, approved by the Government of the Russian Federation. The following general scientific methods are used in the work: analysis and synthesis, system methods, as well as profile-economic, including controlling methods. The scientific novelty of the work lies in the generalization, analysis of the materials considered and in the formation of proposals for certain areas of implementation of the quality management system and conclusions on the development of integration in the medical industry of the member countries of the Eurasian Economic Union as a result of the analysis.