Author(s)

Fu li

Corresponding Author

Fu li

ABSTRACT

In order to improve the quantity and quality of reporting adverse events of medical devices, deal with the occurrence of adverse events in time, prevent the occurrence of adverse events, and ensure the safety of the use of medical devices. Based on BS model, the author studies the monitoring and risk management of adverse events of medical devices. Through the research on the status quo of monitoring the adverse events of medical devices in China, the problems existing in the monitoring work at the current stage are analyzed. At the same time, the main measures that can be taken after the risk management of medical devices are listed, and a brief review of the relevant work in this field in China is carried out. And outlook. The research results show that China's related work in this field has just started, and there is still a lack of systematization, and the regulations and technical systems are in need of improvement.

KEYWORDS

BS mode, medical devices, adverse event detection, risk management