In modern market conditions, any organization, including those engaged in the production of medical devices, must identify risks, carry out their analysis, and determine the degree of their influence on the achievement of goals. This forces enterprises, on the basis of standards for management systems, standards for risk management, including taking into account the specifics of organizations, to implement a risk-based approach, creating their own risk management mechanisms. The article presents and describes in detail the basis for the methodology of the risk management process scheme in the quality management system of an organization engaged in the field of medicine.