医疗器械比对试验组织实施工作的总结与思考

Summary and Thought of Management and Implementation of Interlaboratory Comparisons of Medical Device Testing Institutions

目的为科学、高效的组织管理全国医疗器械检测机构比对试验提供参考。方法通过对已经实施的6次比对试验的经验进行总结与讨论,找出组织管理中的不足。结果与结论提出解决方案并论证其可行性,对比对工作进行总结和展望。

Objective To provide references for the interlaboratory comparisons of medical device testing institutions. Methods Through summarization and thinking of the interlaboratory comparisons of medical device testing institutions, the weak points of management and implementation of the interlaboratory comparisons of medical device testing institutions were found. Results and Conclusion The solutions for the weak points were proposed and the feasibility was demonstrated. The interlaboratory comparison of medical device testing institutions was summarized and its prospect was proposed.