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浅谈医疗器械软件企业质量管理体系的实施 被引量：3

Perspectives on Implementation of Quality Management System in Medical Device Software Enterprises
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摘要 针对医疗器械软件行业的特点及法规、标准要求,讨论质量管理体系中文件管理、软件开发、软件发行与交付、软件维护、软件测试、配置管理、风险管理和缺陷管理等几个过程的实施要点。 Based on the features, regulations and standards of medical device software industry, this paper aimed to discuss the application essentials of document management, software development, software release and delivery, software maintenance, software testing, configuration management, risk management and defect management of quality management system.
作者 罗勇彪
机构地区 广州市奥咨达医疗器械咨询有限公司
出处 《临床医学工程》 2012年第8期1392-1394,共3页 Clinical Medicine & Engineering
关键词 医疗器械 医疗器械软件 质量管理体系 实施 Medical device Medical device software Quality management systems Implement
分类号 R197.39 [医药卫生—卫生事业管理]
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参考文献4

二级参考文献35

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共引文献12

同被引文献26

  • 1胡海珍,苏强,张毅.项目管理在医疗器械质量管理体系建立中的应用研究[J].项目管理技术,2008(S1):58-60. 被引量：2
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引证文献3

二级引证文献3

临床医学工程
2012年 第8期

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