摘要
根据目前相关的医疗器械法规及指导性文件,针对人工智能在医疗器械领域应用的现状及其特性,通过产品研究资料、临床应用等方面对该类产品的在医疗器械领域中的重点问题进行探讨分析。
According to the current relevant medical device regulations and guidance documents,aiming at the current situation and characteristics of the application of artificial intelligence in the field of medical devices,the key problems of this kind of products in the field of medical devices are discussed and analyzed through product research data and clinical application.
作者
王小良
郭嘉杰
WANG Xiao-liang;GUO Jia-jie(Center for Certification and Evaluation,Guangdong Drug Administration,Guangdong Guangzhou 510080)
出处
《中国医疗器械信息》
2021年第11期9-10,170,共3页
China Medical Device Information
基金
中华人民共和国科学技术部项目(课题名称:人工智能医学信息系统软件审评指导体系构建,课题编号:2019YFC018801)。
