英文名称:Medical device software — Part 2: Validation of software for medical device quality systems 标准状态:现行 发布日期:2017-06-13 文档简介 该标准提出了以下基本步骤来进行软件验证: 1.**识别关键任务和软件活动**:识别与软件相关的关键任务以及这些任务相关的软件活动。这些任务和活动应与医疗设备的预...
英文名称:Medical device software - Part 2: Validation of software for medical device quality systems 标准状态:现行 发布日期:2017-06-13 文档简介 该标准是一套用于医疗设备软件质量系统的软件验证的标准,适用于医疗设备软件的开发、测试和确认。以下是该标准的主要内容: ...
© ISO 2017Medical device software —Part 2: Validation of software for medical device quality systemsLogiciels de dispositifs médicaux —Partie 2: Validation des logiciels pour les systèmes de qualité des dispositifs médicauxFirst edition2017-06Reference numberISO/TR 80002-2:2017(E)TECHNICAL REP...
The recent guidance on 21 CFR 11, the upcoming deadline for European CE Marking, and the needs of quality system regulation (QSR) have generated much discussion about approaches to software validation. In this article, a view of software validation by the design team of a QSR medical device ...
FDA Software Validation Validate MATLAB and Simulink for use in a US Food and Drug Administration-regulated medical device design workflow Q. Are MATLAB and Simulink validated or certified by the US FDA? A. The FDA does not currently certify or validate general-purpose software development tools....
This just-published book is written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.ARM Techcon...
The actual process for gaining regulatory approval in the United States is known as apremarket submission. Companies prepare documentation about the device, its software, the verification and validation activities, and the labeling that goes with the device. One aspect significant about the labeling is...
设计验证(design verification)是以客观证据证明设计输出(规范)符合设计输入(要求)。即回答:“我们设计的产品是否正确?(Did we design the device correctly?)。客观证据的定义是:可以通过观察、测量、测试或其他方法证明为属实的信息。 设计确认(design validation)是通过客观证据证明产品规范(设定的技术要求)符合用户需...
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工艺验证是Process Verification的翻译。工艺确认是Process Validation的翻译。也有把它们分别翻译为制造工艺过程验证和确认,或者简称为过程验证和过程确认,或者工艺验证和工艺确认。无论如何翻译,verification总是对应验证,validation总是对应确认,这与设计验证和设计确认的翻译是一致的。