Author(s)

Fu Li

Corresponding Author

Fu Li

Abstract

As a special product, the safety and effectiveness of medical devices are closely related to people's health and even life. The risk of medical devices also includes damage to social property and environment. Therefore, based on the concept of humanization, the author studies the risk management and quality control of medical devices. Introduce the humanization criteria in medical devices and explore the design of medical device products based on the concept of humanity. Research shows that through the particularity of medical products and the analysis of needs and appeals of different users, it is clarified that user research and psychoanalysis are important foundations for humanized design. This research can provide reference for medical device quality management and risk control in large comprehensive hospitals in China.

Keywords

Humanization concept, medical equipment, risk management, quality control