【摘要】 通过对体外诊断试剂产品的技术特性和生产方式的分析,结合目前我国体外诊断试剂行业的现状和所面临的问题,初步研究了该类产品的质量管理体系要点,对企业建立和运行与产品相适应的质量管理体系具有参考作用,也为监管部门进行体外诊断试剂产品的生产监督管理提供了技术参考。更多还原

【Abstract】 This article makes a pilot study on the key points of the quality management system of in-vitro diagnostic reagents by analyzing the technical characteristics and production methods of these products as well as the status in quo, and problems the in-vitro diagnostic reagent industry in China is facing nowadays. It can serve as a reference to the supervision departments and the manufacturers in this field which are establishing and running the quality management system.更多还原