医疗器械软件产品现场检查要点研究
Research on Key Points for On-Site Inspection of Medical Device Software Products
李烜 1刘炳锐1
作者信息
- 1. 天津市医疗器械审评查验中心,天津 300191
- 折叠
摘要
目的 通过梳理2022版《医疗器械注册质量管理体系核查指南》《医疗器械生产质量管理规范独立软件现场检查指导原则》与《医疗器械注册自检管理规定》之间的关系,归纳和分析医疗器械软件产品尤其是注册自检方式现场检查的特殊要求并提供部分检查要点和建议.方法 基于天津市医疗器械审评查验中心非公开数据库,统计13家生产企业的20个医疗器械软件产品现场检查情况,研究医疗器械软件产品的设计开发、生产工艺、质量控制及注册自检等方面的问题,分析医疗器械软件产品现场检查时的关注点.结果 根据现场检查分析情况,总结了部分医疗器械软件产品企业质量体系现场检查的共性问题,提出了部分现场检查尤其是注册自检的特殊要求.结论 本文从设备和厂房设施、质量控制、设计开发、管理体系四个方面提出了医疗器械软件现场检查的要点,为医疗器械软件类产品的质量管理体系检查工作提供了参考和借鉴.
Abstract
Objective To summarize and analyze the special requirements for on-site inspections of medical device software products,especially those that undergo self-inspection during registration,and provide some inspection key points and suggestions by reviewing the relationship between the 2022 edition of the Guidelines for Inspection of Medical Device Registration Quality Management System,the Guiding Principles for On-site Inspections of Independent Software in Medical Device Production Quality Management Practice and the Management Regulations for Medical Device Self-Inspection during Registration.Methods Based on the non-public database of Tianjin Medical Device Evaluation and Inspection Center,the on-site inspection situations of 20 medical device software products from 13 manufacturers were collected.The study focused on issues related to the design and development,production process,quality control and registrant self-inspection of medical device software products.The analysis aimed to identify key areas of concern during on-site inspections.Results Based on the analysis of on-site inspections,common issues in the quality system on-site inspections of enterprises were summarized,and specific requirements for on-site inspections,especially for registrant self-inspection were proposed.Conclusion This paper presents key points for on-site inspections of medical device software from four aspects:equipment and plant facilities,quality control,design and development,and management systems.It provides reference for quality management system inspection of medical device software products.
关键词
医疗器械软件/生产质量管理规范/现场检查/注册自检Key words
medical device software/production quality management practice/on-site inspection/registrant self-inspection引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据