试论医疗器械生产质量管理体系相关问题  

Problems Related to the Production Quality Management System of Medical Devices

作　　者：郭飞飞 GUO Fei-fei(Xiamen Feshuo Biotechnology Co.,Ltd.,Fujian Xiamen 361100)

机构地区：[1]厦门飞朔生物技术有限公司,福建厦门361100

出　　处：《中国医疗器械信息》2024年第1期79-82,共4页China Medical Device Information

摘　　要：在现代化医疗发展过程中,医疗器械的使用非常重要,有助于提高我国现代化医疗水平,满足临床需求。在医疗器械前期生产环节,相关管理人员需要加强对质量控制的重视程度,落实精细化的工作原则,严格按照医疗器械生产质量管理规范的要求,约束好不同的工作行为,减少医疗器械质量问题的发生概率,使医疗器械生产质量管理效果能够符合预期的要求,为后续使用奠定坚实的基础。In the process of the development of China’s modern medical industry,the use of medical devices is more important,which can not only help to meet the clinical requirements,but also help to highlight the level of China’s modern medical treatment.In the early stage of medical device production,related managers need to strengthen the importance of quality control,implement the working principle of refinement,in strict accordance with the requirements of medical device production quality management specification,constraint different work behavior,reduce the occurrence probability of medical device quality problems,make the quality management of medical device production effect can meet the expected requirements,to lay a solid foundation for subsequent use.

关 键 词：医疗器械 生产质量 管理研究 

分 类 号：R197.39[医药卫生—卫生事业管理]