摘要
为提升医疗器械检验检测实验室的综合服务能力,以数字化手段赋能检验检测业务活动,完成实验室业务全生命周期的数字化。本文对省级医疗器械检验机构实验室的数字化提出了建设思路与设计方案,设计了数字化实验室的设计原则和技术路线及架构,构建了业务能力与数字能力的应用建设场景,强化了检验检测业务质量体系,利用日常委托、监督抽验、注册检验、快速测评、不良/警示/召回的风险监测分析与应用,有利于更好地服务监管、服务企业。
In order to improve the comprehensive service capabilities of medical device inspection and testing laboratories,the inspection and testing business activities are empowered by digital means,and complete the digitization of the entire lifecycle of laboratory business.This article proposed a construction idea and design plan for the digitization of provincial medical device inspection institutions laboratories,designed the design principles,technical routes,and architecture of digital laboratories,constructed application scenarios for business and digital capabilities,strengthened the quality system of inspection and testing business,and utilized risk monitoring analysis and application of daily commissioning,supervision sampling,registration inspection,rapid evaluation,and defect/warning/recall to better serve supervision and enterprises.
作者
孙晶
马宁
SUN Jing;MA Ning(Jiangsu Institute of Medical Device Testing,Nanjing 210000,China;Nanjing Sanchahe River Estuary Sluice Management Officer,Nanjing 210000,China)
出处
《实验室检测》
2024年第9期71-74,共4页
Laboratory Testing
关键词
实验室
数字化平台
医疗器械
laboratory
digital platform
medical devices
