新发展阶段医疗器械管理的优化策略探讨  

Discussion on the Optimization Strategy of Medical Device Management in the New Development Stage

作　　者：翟文雅 ZHAI Wen-ya(Beijing Zhongjian Antai Diagnostic Technology Co.,Ltd.,Beijing 102629)

机构地区：[1]北京中检安泰诊断科技有限公司,北京102629

出　　处：《中国医疗器械信息》2025年第5期157-159,共3页China Medical Device Information

摘　　要：医疗行业与社会民生联系密切,伴随着医疗行业的蓬勃发展,医疗器械行业得到了同步发展,医疗器械类型丰富多样,产品质量得到了大幅度提升。但不可否认的是,市场上的医疗器械生产企业数量众多,有些企业由于管理不当,技术水平不高等因素存在,不同程度上影响到医疗器械的质量和安全。因此,文章主要立足于新发展阶段,探究医疗器械管理的优化策略,期待为医疗器械生产企业的日常管理提供参考依据。The medical industry is closely related to the society and people’s livelihood.With the vigorous development of the medical industry,the medical device industry has been developing simultaneously,the types of medical devices are rich and diverse,and the product quality has been greatly improved.However,it is undeniable that there are a large number of medical device manufacturers in the market.Some enterprises affect the quality and safety of medical devices to varying degrees due to the influence of improper management and low technical level.Therefore,the article is mainly based on the new development stage,exploring the optimization strategy of medical device management,and expecting to provide a reference basis for the daily management of medical device manufacturers.

关 键 词：医疗器械管理 管理体系 质量管理 产品检测 

分 类 号：R197.39[医药卫生—卫生事业管理]