本文在全面分析医疗器械的风险管理概念的基础上,指出了医疗器械风险管理过程活动的要点,以及如何辩证地处理风险管理活动发生的问题,在此基础上,文章进一步分析了医疗器械行政监管活动对医疗器械风险的影响,对如何用风险管理的基本理念调整和强化医疗器械的行政监管活动做了详细的研究和思考。
<<On the basis of comprehensive analysis of the concept of medical device risk management,this paper points out the main points in the process of medical device risk management activities and how to dialectical deal with the problem when it occurs. On this basis,this paper further analyzes the influence factor of medical device administrative supervision for the risks of medical device,presents a detail analysis on how to use the basic concepts of risk management to adjust and strengthen the activities of administrative supervision.
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