Thoughts and Suggestions on Risk Management of Medical Device Clinical Trials
Objective:To improve the risk awareness of all participants in clinical trials of medical devices,improve quality management level,to provide guarantee and technical supports for the construction of scientific supervision of medical devices.Methods:Combined with years of medical device clinical trial supervision experience and inspection data,the risk factors of all aspects of clinical trials of medical devices were analyzed,and corrective and preventive measures were proposed.Results and Conclusion:There were great differences in risks among products in clinical trials of medical devices.It was difficult to design a good scheme,and the dependence on the main investigator was strong.The current regulatory model was single.Strengthening all-round risk management will effectively improve the quality management level of medical device clinical trials and promote the healthy and rapid development of the entire medical device industry.
medical deviceclinical trialsrisk managementquality controlscientific supervision
NETL
NSTL
万方数据
