Understanding the intricacies of medical device translation

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作者
Globalization and Localization Association , Andover, MA [1 ]
不详 [2 ]
机构
来源
Med. Device Diagn. Ind. | 2006年 / 8卷 / 72-80期
关键词
Biomedical engineering - Firmware - Laws and legislation - Marketing - Medical applications - Product development;
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摘要
Medical device companies, who are looking to globalize their products, are required to consider the effect that translation can have on a product's success. There is a complicated and time-consuming web of regulations and marketing issues that must be addressed in the global product development. Device manufacturers should not wait until the final stages of development to begin addressing the translation process. It is important to get it right the first time because a poorly translated product can damage the company's reputation. Companies must have standard operating procedure in place, be familiar with the target markets' regulations regarding translation, and begin the process of translation early. The translation process should include all documentation, packaging, software, hardware and firmware. The efficient translation process can ensure the confirmation to local regulations, and convey the message of the product accurately and professionally.
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