药学研究2025，Vol.44Issue(8)：774-778,785,6.DOI:10.13506/j.cnki.jpr.2025.08.008
人工智能时代背景下医疗器械生产企业远程监管的探索与思考及相关实施策略
Exploration and reflection on the implementation strategy of remote supervision in the production process of medical device manufacturers in the context of the artificial intelligence
刘锜 1马超 2苏小徽 1许珲3
作者信息
- 1. 山东省市场监管监测中心,山东济南 250012
- 2. 山东省食品药品检验研究院,山东济南 250101
- 3. 山东省医疗器械和药品包装检验研究院,山东济南 250101
- 折叠
摘要
Abstract
AI-enabled remote supervision of production processes represents a critical pathway for the government's innovative regulatory models,strengthening digital government construction,and achieving intelligent supervision.Addressing the pain points of traditional on-site inspections in the medical device industry-such as geographical,spatial,and resource constraints-this paper focused on how to effectively implement remote supervision of production processes within this sector in the era of artificial intelligence.By analyzing the current state and challenges of industry supervision,and drawing on practical remote supervision experience from diverse fields both domestically and internationally,as well as the application outcomes of AI,this study aimed to explore and propose remote supervision methods and implementation strategies tailored to the characteristics of the medical device industry.关键词
医疗器械监管/远程监管/智慧监管/监管创新/人工智能Key words
Supervision of medical device/Remote supervision/Intelligent supervision/Regulatory innovation/Artificial intelligence分类
医药卫生引用本文复制引用
刘锜,马超,苏小徽,许珲..人工智能时代背景下医疗器械生产企业远程监管的探索与思考及相关实施策略[J].药学研究,2025,44(8):774-778,785,6.
