Donawa Maria
Donawa Consulting, Rome, Italy.
Med Device Technol. 2008 Sep;19(5):32, 34-7.
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.
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存在显著差异。当重新测试或进行设备重新设计变得必要时，不解决这些差异可能会代价高昂。本文讨论了其中一些差异以及有助于避免重复测试的方法。
