本文選題：胱抑素C校準(zhǔn)品 + 風(fēng)險(xiǎn)管理��； 參考：《中國(guó)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(guó)醫(yī)療器械生產(chǎn)企業(yè)實(shí)施風(fēng)險(xiǎn)管理現(xiàn)狀和問(wèn)題的基礎(chǔ)上,以胱抑素C校準(zhǔn)品的研發(fā)實(shí)證為例,探討了將國(guó)際標(biāo)準(zhǔn)IS014971應(yīng)用于產(chǎn)品研發(fā)過(guò)程中的具體實(shí)施方法,為提升產(chǎn)品的安全性提供思路。 本文通過(guò)文獻(xiàn)查閱、專家咨詢、實(shí)證研究,以胱抑素C校準(zhǔn)品研發(fā)過(guò)程中實(shí)施的風(fēng)險(xiǎn)管理為例,梳理了對(duì)體外診斷試劑進(jìn)行風(fēng)險(xiǎn)管理的流程,明確了生產(chǎn)企業(yè)在產(chǎn)品設(shè)計(jì)開(kāi)發(fā)階段、產(chǎn)品上市后及異常情況下需要具體實(shí)施的風(fēng)險(xiǎn)管理活動(dòng)；詳細(xì)介紹了體外診斷試劑研制過(guò)程中實(shí)施的風(fēng)險(xiǎn)分析的方法,探討了如何按照風(fēng)險(xiǎn)控制的要求和風(fēng)險(xiǎn)控制方案對(duì)產(chǎn)品進(jìn)行風(fēng)險(xiǎn)控制的方法。 研究結(jié)果表明：北京萬(wàn)泰德瑞診斷技術(shù)有限公司(以下簡(jiǎn)稱萬(wàn)泰德瑞公司)通過(guò)對(duì)胱抑素C校準(zhǔn)品在研制過(guò)程中進(jìn)行有效的風(fēng)險(xiǎn)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(cè)證書提供質(zhì)量保障,使該產(chǎn)品在市場(chǎng)上替代DAK0公司的胱抑素C校準(zhǔn)品成為可能。目前萬(wàn)泰德瑞公司的胱抑素C校準(zhǔn)品,在市場(chǎng)上產(chǎn)品質(zhì)量?jī)?yōu)勢(shì)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(xiǎn)管理為例,探討了體外診斷試劑產(chǎn)品研制過(guò)程中具體的風(fēng)險(xiǎn)管理應(yīng)用,總結(jié)該產(chǎn)品風(fēng)險(xiǎn)管理的經(jīng)驗(yàn),期望能為同行業(yè)廠家產(chǎn)品的研制時(shí)的風(fēng)險(xiǎn)管理工作提供一些經(jīng)驗(yàn)。
[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(guó)科學(xué)院大學(xué)(工程管理與信息技術(shù)學(xué)院)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2013
【分類號(hào)】：F426.72;F272.3

【參考文獻(xiàn)】

相關(guān)期刊論文 前7條

1 陳志剛;;關(guān)于醫(yī)療器械風(fēng)險(xiǎn)管理標(biāo)準(zhǔn)的幾點(diǎn)認(rèn)識(shí)[J];中國(guó)醫(yī)學(xué)裝備;2009年06期

2 趙玉杰;屈浩鵬;盧宇;;醫(yī)療器械生產(chǎn)企業(yè)風(fēng)險(xiǎn)管理分析及建議[J];首都醫(yī)藥;2009年21期

3 孟杰雄;王燕;劉志成;;醫(yī)療器械風(fēng)險(xiǎn)分析方法的介紹與應(yīng)用展望[J];中國(guó)醫(yī)療器械信息;2007年01期

4 陳志剛;王慧芳;;學(xué)習(xí)貫徹YY/T0316-2008/ISO14971:2007風(fēng)險(xiǎn)管理標(biāo)準(zhǔn) 確保將醫(yī)療器械風(fēng)險(xiǎn)控制在可接受水平[J];中國(guó)醫(yī)療器械信息;2009年02期

5 王抒,李培瑛,陳文祥,董軍,蔣雷,國(guó)漢邦,唐蔚青,李紅霞,李健齋;血清膽固醇標(biāo)準(zhǔn)參考物質(zhì)的研制[J];中華醫(yī)學(xué)檢驗(yàn)雜志;1996年04期

6 張素敏;張亮;;國(guó)內(nèi)外醫(yī)療器械風(fēng)險(xiǎn)管理現(xiàn)狀分析[J];中國(guó)醫(yī)療器械雜志;2010年06期

7 呂大雷;李非;魏晶;楊悅;;醫(yī)療器械生產(chǎn)企業(yè)對(duì)風(fēng)險(xiǎn)管理認(rèn)知程度的調(diào)查[J];中國(guó)執(zhí)業(yè)藥師;2009年07期

，

本文編號(hào)：1914130