Author(s)

Chao Zhang

Corresponding Author

Chao Zhang

ABSTRACT

Medical devices, as a type of commodity closely related to human health, often cause medical accidents and significant economic losses and social impacts once quality problems occur. With the rapid expansion and development of the medical device industry and the continuous deepening of supervision and management work by supervisory departments, some problems in the production and operation of the medical device industry have gradually been exposed. This article analyzes the future development direction and management mode of business management in medical device enterprises, identifies existing problems, provides a basis for improving the supervision system, and ultimately integrates risk management into and becomes an indispensable part of the enterprise quality management system. For problems found during inspection, close tracking should be carried out to ensure product quality. The disinfection supply room should fully utilize existing equipment and human resources, achieve resource sharing, and centrally manage the washing, packaging, sterilization, and distribution of recycled medical devices, so that production enterprises and other personnel can establish a concept of full life cycle risk management.

KEYWORDS

Business management of medical device enterprises, Future development direction, Management model