医疗器械生产质量管理体系中物料与产品管理探析  

Analysis of Material and Product Management in Medical Device Production Quality Management System

作　　者：陈俊华 CHEN Jun-hua(Shenzhen Mindray Biomedical Electronics Co.,Ltd.,Guangdong Shenzhen 518107)

机构地区：[1]深圳迈瑞生物医疗电子股份有限公司,广东深圳518107

出　　处：《中国医疗器械信息》2024年第9期65-67,共3页China Medical Device Information

摘　　要：医疗器械生产管理是确保医疗器械产品质量的关键环节,重点在于监控和提升生产质量。随着医疗卫生事业的快速发展,医疗器械生产质量管理体系正朝着更高的标准和更先进的方向发展。在确保安全、科学和有效性的基础上,加强医疗卫生器械的管理力度和深度,是提升企业内部医疗器械质量管理模式的可行性、可操作性和灵活性的关键。这不仅有助于实现经济效益的最大化,也能增强企业在竞争激烈的市场环境中的核心竞争力,还可为同类型的医疗器械生产厂家提供宝贵的借鉴和指导,促进整个行业的稳定和可持续发展。Medical device production management is a key link to ensure the quality of medical device products,focusing on monitoring and improving production quality.With the development of medical and health care,the medical device production quality management system is developing towards a higher standard and a more advanced direction.On the basis of ensuring safety,science and effectiveness,strengthening the management intensity and depth of medical and health devices is the key to improving the feasibility,operability and flexibility of the internal medical device quality management model.This not only helps to maximize economic benefits,but also enhances the core competitiveness of enterprises in a highly competitive market environment,and can also provide valuable reference and guidance for the same type of medical device manufacturers to promote the stability and sustainable development of the entire industry.

关 键 词：医疗器械 生产质量管理体系 物料 产品管理 

分 类 号：R197.39[医药卫生—卫生事业管理]