解决美国和欧洲的设备测试要求。

Medical device technology Pub Date : 2008-09-01

Maria Donawa

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引用次数: 0

摘要

医疗器械公司并不总是意识到美国和欧洲的测试要求可能有很大的不同。当需要重新测试或重新设计设备时，不解决这些差异可能会代价高昂。本文将讨论其中的一些差异，以及帮助避免重复测试的方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Addressing US and European device testing requirements.

Medical device companies do not always realise that United States and European test requirements can be significantly different. Not addressing these differences can be costly when retesting or device redesign becomes necessary. This article discusses some of these differences and ways to help avoid repeat testing.

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来源期刊

Medical device technology

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