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【題記】本文來自2017年9月21日MEDTEC展會上,，第二屆先進制造論壇的主題分享PPT,。醫(yī)療器械質(zhì)量風險管理是醫(yī)療器械行業(yè)的技術(shù)難點之一。本文作者從風險管理的概念和原理,、風險管理的流程,、風險管理的潛在應(yīng)用、風險分析的方法,、風險受益比的思考五個方面進行了分享與探討,，僅供醫(yī)療器械從業(yè)者們討論和學(xué)習(xí)。

【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.