Quality assurance of medical devices production

The article is devoted to a comprehensive study of the implementation of a quality management system at manufacturing enterprises of medical devices that comply with the principles and requirements of the interstate standard GOST ISO 13485-2017 "Medical devices. Quality management systems. Requirements for regulatory purposes". The author focuses on the characteristic distinctive requirements of the standard for the production of medical devices. The author attempts to describe the distinctive features of the production of medical devices, including when using various management systems and integrated management systems at the enterprise. Studying the specifics of the activities of various organizations, the author offers a number of recommendations, since the author of the work concludes that in order to meet the requirements of GOST ISO 13485-2017, it is also necessary to consider the need to use a number of other standards related to this type of activity in the manufacture of medical devices. To compare the initial parameters and characteristics of the studied types of activities of organizations, the work examines the activities of enterprises producing national economic products certified for compliance with GOST R ISO 9001-2015 and the activities of enterprises engaged in the production of medical devices certified for compliance with GOST ISO 13485-2017. The article reveals the specifics of the application of regulatory requirements and suggests options for possible solutions to emerging conflicts in the conduct of this type of activity. Based on the study of regulatory sources, the author found that there is a need for enterprises in the real sector of the economy to find and develop acceptable solutions to this issue. The work is interdisciplinary in nature and will be of interest to quality specialists, as well as enterprises that manufacture medical devices.