关键词: font-size:medium, ">医疗器械不良事件；医疗器械警戒；风险管理；模式分析；提升监测措施

Abstract: This study focuses on the field of adverse event monitoring of medical devices. By analyzing the risk management processes and models of medical devices after they are launched on the market， it examines the existing problems in the current adverse event monitoring system of medical devices. From the perspective of the work of grassroots monitoring institutions， it proposes measures such as strengthening cross-departmental collaboration， promoting standardization and intelligent construction， improving monitoring technical means， optimizing the paths and mechanisms for risk reporting， strengthening the main responsibility of the registrants in monitoring， and enriching monitoring tools. It explores several key focal points for constructing the medical device vigilance system， with the aim of providing useful ideas and references for the in-depth implementation of medical device vigilance work.

Key words: font-size:medium, ">Medical device adverse events； Medical device vigilance； Risk management； Pattern analysis； Enhance monitoring measures