發(fā)布時(shí)間：2018-01-05 05:11

  本文關(guān)鍵詞：醫(yī)療器械研發(fā)項(xiàng)目風(fēng)險(xiǎn)管理研究　出處：《中國科學(xué)院大學(xué)（工程管理與信息技術(shù)學(xué)院）》2014年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 醫(yī)療器械研發(fā) 風(fēng)險(xiǎn)識別 風(fēng)險(xiǎn)分析 風(fēng)險(xiǎn)控制

【摘要】：醫(yī)療器械研發(fā)項(xiàng)目具有跨學(xué)科、難度大、周期長、法規(guī)要求嚴(yán)格等特點(diǎn),由此也決定了它的高風(fēng)險(xiǎn)特征。如何有效地規(guī)避醫(yī)療器械研發(fā)的高風(fēng)險(xiǎn)是我國醫(yī)療器械研發(fā)工作者的迫切要求和艱巨任務(wù)。因此,分析醫(yī)療器械研發(fā)活動中存在的風(fēng)險(xiǎn)因素,進(jìn)行有效的風(fēng)險(xiǎn)管理,對于我國醫(yī)療器械產(chǎn)業(yè)可持續(xù)發(fā)展有著十分重要的理論意義和現(xiàn)實(shí)意義。 本文將在理論研究的基礎(chǔ)上,結(jié)合醫(yī)療器械研發(fā)項(xiàng)目實(shí)例,運(yùn)用項(xiàng)目風(fēng)險(xiǎn)管理的知識和方法,從項(xiàng)目角度出發(fā)對醫(yī)療器械研發(fā)項(xiàng)目的風(fēng)險(xiǎn)管理進(jìn)行探索。作者完成的主要工作包含以下幾個(gè)方面的內(nèi)容： (1)簡單介紹了本文的研究背景和意義,在參閱相關(guān)文獻(xiàn)資料的基礎(chǔ)上,綜合描述了醫(yī)療器械風(fēng)險(xiǎn)管理的現(xiàn)狀和進(jìn)展。 (2)對醫(yī)療器械研發(fā)企業(yè)的組織機(jī)構(gòu)和項(xiàng)目開發(fā)過程進(jìn)行了詳細(xì)的梳理,協(xié)調(diào)組織由相關(guān)領(lǐng)域?qū)＜医M成風(fēng)險(xiǎn)管理小組采用訪談、頭腦風(fēng)暴等方法對可能出現(xiàn)的風(fēng)險(xiǎn)因素進(jìn)行了識別,識別出醫(yī)療器械研發(fā)項(xiàng)目可能出現(xiàn)的5類16種風(fēng)險(xiǎn)因素形成風(fēng)險(xiǎn)因素清單,采取問卷調(diào)查的形式對形成的風(fēng)險(xiǎn)因素清單進(jìn)行實(shí)證研究,確保其準(zhǔn)確性和客觀性。 (3)采用層次分析法構(gòu)造判斷矩陣對各風(fēng)險(xiǎn)因素進(jìn)行了重要度排序,形成研發(fā)各階段主要風(fēng)險(xiǎn)清單,根據(jù)不同風(fēng)險(xiǎn)類型按照減輕、規(guī)避、分擔(dān)和接受的策略制定了合理的風(fēng)險(xiǎn)應(yīng)對措施,并對風(fēng)險(xiǎn)的應(yīng)對情況進(jìn)行監(jiān)控。 (4)以高強(qiáng)度聚焦超聲治療系統(tǒng)研發(fā)項(xiàng)目風(fēng)險(xiǎn)管理作為研究案例,按照以上的理論方法對其實(shí)施風(fēng)險(xiǎn)管理,分析其中的風(fēng)險(xiǎn)并加以控制,達(dá)到對理論研究的可行性和可操作性加以驗(yàn)證的目的。 本文是對醫(yī)療器械研發(fā)過程從項(xiàng)目角度應(yīng)用風(fēng)險(xiǎn)管理知識和方法的一次探索性研究,其研究成果對醫(yī)療器械研發(fā)工作有一定的指導(dǎo)和參考價(jià)值,同時(shí)也有助于項(xiàng)目風(fēng)險(xiǎn)管理理論的進(jìn)一步深化。
[Abstract]:Medical device R & D project has the characteristics of interdisciplinary, difficult, long cycle, strict regulations and so on. This also determines its high risk characteristics. How to effectively avoid the high risk of medical device research and development is the urgent requirement and arduous task of medical device R & D workers in China. It is of great theoretical and practical significance for the sustainable development of medical device industry to analyze the risk factors existing in the research and development of medical devices and carry out effective risk management. On the basis of theoretical research, this paper will use the knowledge and methods of project risk management in combination with the example of medical device R & D project. This paper explores the risk management of the medical device R & D project from the perspective of the project. The main work accomplished by the author includes the following aspects: This paper briefly introduces the research background and significance of this paper and describes the current situation and progress of medical device risk management on the basis of referring to relevant literature. The organization organization and project development process of the medical device R & D enterprise are combed in detail, and the coordination organization is composed of experts in the related field to form the risk management group to adopt the interview. Brainstorming and other methods identified the possible risk factors, and identified 5 types of 16 risk factors that may appear in the R & D project of medical devices to form a list of risk factors. The form of questionnaire survey is used to make an empirical study on the list of risk factors to ensure its accuracy and objectivity. (3) Analytic hierarchy process (AHP) is used to construct judgment matrix to rank the importance of each risk factor, and to form the main risk list in each stage of R & D, according to different risk types according to mitigation and avoidance. The strategy of sharing and accepting makes reasonable measures to deal with risk, and monitors the situation of risk response. Taking the research and development project risk management of high-intensity focused ultrasound therapy system as a case study, according to the above theoretical methods to implement risk management, analyze the risk and control it. The feasibility and maneuverability of the theoretical research are verified. This paper is an exploratory study on the application of risk management knowledge and methods in the process of medical device R & D from the perspective of the project. The research results have certain guidance and reference value for the R & D of medical device. At the same time, it also helps to deepen the theory of project risk management.
【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】：2014
【分類號】：F426.4

【引證文獻(xiàn)】

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