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Quality assurance from a manufacturer's standpoint

机译:制造商的立场质量保证

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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:制造商在组件采购验收测试领域的努力非常明显,而在设计和制造医学成像设备期间正在进行的质量保证工作通常不是那么明显。成像设备的设计和生产中的许多步骤经过精心设计,不仅在最初安装时促进设备的质量,而且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,安全和监管合规性的要求。代表现代产品设计工程超过70%的软件呈现出特别挑战,因为无法测试软件质量,必须设计。特定的硬件元件,如监控荧光粉颜色和均匀性等等。一种允许快速诊断和更换失败组件的设计也很重要。

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