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[Analysis of Common Questions in Medical Device Technical Review]
Keying Sun1, Zhaojun Guo1, Ruonan Jin1
1Center for Medical Device Evaluation, NMPA, Beijing, 100081.
Abstract:
Risk management is an activity running through the full life of medical device, which has a significant effect on ensuring the safety and effectiveness of medical device. Many researchers do the research on medical device risk management from different perspectives, but few people discuss it from the technical perspective. The risk management issue in technical review of medical equipment was discussed, the reasons of the issue were analyzed, and suggestions were given in this study.
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