Abstract:Objective Through statistical analysis of unannounced inspection findings of medical device manufacturer from 2016 to
2017, the high-frequency defective items can be found and the reasons can be analyzed. Methods The findings of different types of
medical device manufacturers were statistically analyzed. Results Document and record, plant and facility, production management
and quality management were sections of the clauses that had a high frequency defection. Conclusion The investment for clean
room and medical water system need to be increased in their own needs, and the effective operation of the quality system needs more
high-quality staff.
鲍方名. 2016~2017年医疗器械生产企业飞行检查缺陷分析[J]. 中国医疗设备, 2019, 34(2): 137-140.
BAO Fangming. Unannounced Inspection Finding Analysis of Medical Device Manufacturer From 2016 to 2017. China Medical Devices, 2019, 34(2): 137-140.