ABSTRACT
Clinical research of artificial intelligence (AI) medical devices is one of the most important links in the process of AI medical devices product development. This paper discusses the key elements of the ethical review of clinical research of artificial intelligence medical devices and the four aspects including strengthening the legislative construction and supervision, strengthening the capacity building of the ethics committee, improving the ethical review system and system construction, expanding platform construction and strengthening regional linkage that can improve the quality of ethical review in the future, protect the safety of subjects, and ensure the efficiency and quality of clinical research.
ABSTRACT
OBJECTIVE@#To understand the current situation of artificial intelligence production enterprise quality management system, so as to provide reference basis for the research and standardization of Artificial Intelligence Medical Device (AIMD) product quality management.@*METHODS@#Based on YY/T 0287-2017 Medical Device Quality Management System for Regulatory Requirements, Medical Equipment Production and the Quality Control Standard for Independent Software Appendix and Xavier GMLP report, the relevant factors were screened and the questionnaire was designed by combining expert consultation and literature review. Then, a total of 32 representative AIMD enterprises were invited to fill in the questionnaire. Descriptive statistical analysis was performed on the data results using Excel 2016.@*RESULTS@#Through in-depth analysis of the four themes in product planning and design, result output, product quality control and product change, it was found that it was necessary for enterprises participating in the survey to improve the quality management system of AIMD products to different degrees.@*CONCLUSIONS@#This study is the first time to systematically investigate the status quo of quality management of AIMD enterprises. The result will be useful for the establishment and continuous improvement of product quality management system. It will also provide a reference for the research of AIMD product quality management and the establishment of the standard.