医疗器械质量风险管理的潜在应用

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【题记】本文来自2017年9月21日MEDTEC展会上，第二届先进制造论坛的主题分享PPT。医疗器械质量风险管理是医疗器械行业的技术难点之一。本文作者从风险管理的概念和原理、风险管理的流程、风险管理的潜在应用、风险分析的方法、风险受益比的思考五个方面进行了分享与探讨，仅供医疗器械从业者们讨论和学习。

【Introduction】This article is based on a presentation of second Advanced Manufacturing forum at MEDTEC convention on September 21th,2017. Medical Device Quality Risk Management is a difficult technical point in medical device industry. The author layouts and discusses five different aspects in this article-Concepts and Principles of Risk Management, Risk Management Process, Potential Applications of Risk Management, Methods of Risk Analysis, Risk-Benefit Ratio. Welcome all the friends share and discuss their opinions towards this topic.