AIM: Exploring medical device clinical trial quality management indicator system to continuously improve medical device clinical trial quality system construction. METHODS: Through literature research and Delphi method, we summarized the risks of medical device clinical trials in various aspects such as quality management, clinical trial data, and clinical trial research personnel construction, analyzed the risks and proposed a clinical trial quality management index system, as well as corresponding quality improvement measures. RESULTS: To establish an appropriate medical device clinical trial quality evaluation management tool for quality risk monitoring and management, and to support and help the construction of a medical device clinical trial quality management system. CONCLUSION: To identify risks in various aspects of clinical trials and establish a preliminary assessment index system to provide a reference for the evaluation of the effectiveness of clinical trial quality management.