本文選題：胱抑素C校準(zhǔn)品 + 風(fēng)險管理��； 參考：《中國科學(xué)院大學(xué)(工程管理與信息技術(shù)學(xué)院)》2013年碩士論文

【摘要】：本文在分析我國醫(yī)療器械生產(chǎn)企業(yè)實施風(fēng)險管理現(xiàn)狀和問題的基礎(chǔ)上,以胱抑素C校準(zhǔn)品的研發(fā)實證為例,探討了將國際標(biāo)準(zhǔn)IS014971應(yīng)用于產(chǎn)品研發(fā)過程中的具體實施方法,為提升產(chǎn)品的安全性提供思路。 本文通過文獻(xiàn)查閱、專家咨詢、實證研究,以胱抑素C校準(zhǔn)品研發(fā)過程中實施的風(fēng)險管理為例,梳理了對體外診斷試劑進(jìn)行風(fēng)險管理的流程,明確了生產(chǎn)企業(yè)在產(chǎn)品設(shè)計開發(fā)階段、產(chǎn)品上市后及異常情況下需要具體實施的風(fēng)險管理活動；詳細(xì)介紹了體外診斷試劑研制過程中實施的風(fēng)險分析的方法,探討了如何按照風(fēng)險控制的要求和風(fēng)險控制方案對產(chǎn)品進(jìn)行風(fēng)險控制的方法。 研究結(jié)果表明：北京萬泰德瑞診斷技術(shù)有限公司(以下簡稱萬泰德瑞公司)通過對胱抑素C校準(zhǔn)品在研制過程中進(jìn)行有效的風(fēng)險管理,確保了該校準(zhǔn)品的安全有效性,為該產(chǎn)品獲得北京市食品藥品監(jiān)督管理審批的注冊證書提供質(zhì)量保障,使該產(chǎn)品在市場上替代DAK0公司的胱抑素C校準(zhǔn)品成為可能。目前萬泰德瑞公司的胱抑素C校準(zhǔn)品,在市場上產(chǎn)品質(zhì)量優(yōu)勢明顯,有較好的口碑,其銷售也取得了良好的的經(jīng)濟(jì)效益。 總之本文以胱抑素C校準(zhǔn)品研發(fā)階段的風(fēng)險管理為例,探討了體外診斷試劑產(chǎn)品研制過程中具體的風(fēng)險管理應(yīng)用,總結(jié)該產(chǎn)品風(fēng)險管理的經(jīng)驗,期望能為同行業(yè)廠家產(chǎn)品的研制時的風(fēng)險管理工作提供一些經(jīng)驗。
[Abstract]:On the basis of analyzing the current situation and problems of implementing risk management in medical device manufacturing enterprises in China, this paper discusses the concrete implementation methods of applying international standard IS014971 to product development by taking the research and development of cystatin C calibrator as an example. To improve the safety of products to provide ideas. In this paper, through literature review, expert consultation, empirical research, taking the risk management of cystatin C calibration product as an example, the process of risk management of in vitro diagnostic reagent is combed. The risk management activities that need to be carried out in the stage of product design and development, after the product going on the market and under abnormal circumstances are clarified, and the methods of risk analysis in the development of in vitro diagnostic reagents are introduced in detail. This paper discusses how to carry out risk control according to the requirement of risk control and the method of risk control. The results show that: Beijing Wantaideri Diagnostic Technology Co., Ltd. (hereinafter referred to as Wantaideri Company) through the development of cystatin C calibration product through effective risk management, to ensure the safety and effectiveness of the calibration, Quality assurance is provided for the registration certificate approved by Beijing Food and Drug Administration, which makes it possible for the product to replace DAK0's cystatin C calibrator in the market. At present, the cystatin C calibrator of Vantaideri Company has obvious advantages of product quality and good reputation in the market, and its sales have also achieved good economic benefits. In a word, taking the risk management of cystatin C calibration product as an example, this paper discusses the application of risk management in the development of in vitro diagnostic reagent, and summarizes the experience of risk management in the product. It is expected to provide some experience for the risk management of product development in the same industry.
【學(xué)位授予單位】：中國科學(xué)院大學(xué)(工程管理與信息技術(shù)學(xué)院)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2013
【分類號】：F426.72;F272.3

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本文編號：1914130