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Quality assurance from a manufacturer's standpoint

机译:从制造商的角度保证质量

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Abstract: The efforts of a manufacturer in the area of component procurement acceptance testing are very visible, while the quality assurance work that goes on during the design and manufacture of medical imaging equipment is frequently not so apparent. Many steps in the design and production of imaging devices are carefully designed to promote not only quality of the devices when initially installed, but also the ability to maintain the device's quality over a period of time. Customer requirements for aesthetics, performance, safety and regulatory compliance must be considered. Software, which represents over 70% of the design engineering of modern products, presents a special challenge since the quality of software cannot be tested and must be designed in. Specific hardware elements such as monitor phosphor color and uniformity deserve extra consideration. A design that allows quick diagnosis and replacement of failed components is also important. !
机译:摘要:制造商在零件采购验收测试领域的努力是显而易见的,而在医学成像设备的设计和制造过程中进行的质量保证工作却往往不那么明显。成像设备的设计和生产中的许多步骤都经过精心设计,不仅可以提高最初安装时设备的质量,还可以提高在一段时间内保持设备质量的能力。必须考虑客户对美学,性能,安全性和合规性的要求。代表现代产品设计工程70%以上的软件提出了一个特殊的挑战,因为无法测试软件的质量,必须对其进行设计。特定的硬件元素(如监视器磷光体的颜色和均匀性)值得额外考虑。快速诊断和更换故障组件的设计也很重要。 !

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