基于科學(xué)監(jiān)管的醫(yī)療器械檢驗(yàn)檢測大數(shù)據(jù)平臺研究

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【摘要】本文針對醫(yī)療器械檢驗(yàn)檢測機(jī)構(gòu)數(shù)據(jù)，設(shè)計(jì)建立基于科學(xué)監(jiān)管的醫(yī)療器械檢驗(yàn)檢測機(jī)構(gòu)大數(shù)據(jù)平臺，以此有效提高服務(wù)客戶質(zhì)量和控制內(nèi)部質(zhì)量。此外，建立醫(yī)療器械行業(yè)大數(shù)據(jù)平臺，將醫(yī)療器械生產(chǎn)單位、檢驗(yàn)檢測機(jī)構(gòu)、使用單位、監(jiān)管部門的數(shù)據(jù)實(shí)現(xiàn)信息化，用數(shù)據(jù)驅(qū)動醫(yī)療器械科學(xué)監(jiān)管，提升服務(wù)水平和能力。

【關(guān)鍵詞】醫(yī)療器械；檢驗(yàn)檢測；大數(shù)據(jù)；科學(xué)監(jiān)管

【DOI編碼】10.3969/j.issn.1674-4977.2023.05.037

Research on Big Data Platform for Medical Device Inspection and Detection Based on Scientific Supervision

CHEN Xiuwen1， XU Xinrong1， LIU Bin2*， DING Jinju2， LIAN Xiaoqi2

（1.Medical Device Research and Testing Center of South China University of Technology， Guangzhou 537199， China； 2.Dawan Branch Center for Technical Evaluation and Inspection of Medical Devices， National Medical ProductsAdministration， Shenzhen 518000， China）

Abstract： Based on the data of medical device inspection and testing institutions， this paper designs and establishes a Big data platform for medical device inspection and testing institutions based on scientific supervision to effectively improve customer service quality and control internal quality. In addition， establish a Big data platform for the medical device industry to make the data of medical device manufacturers， inspection and testing institutions， users， and regulatory authorities informationized， and use data to drive scientific supervision of medical devices to improve service levels and capabilities.

Key words： medical devices； inspection and testing； big data； scientific regulation

近年來，我國醫(yī)療器械產(chǎn)業(yè)保持快速發(fā)展，成為生命健康領(lǐng)域發(fā)展最快的行業(yè)。（剩余4395字）