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Translating Medical Labeling

July 23, 2014

Translations and Medical Labeling

For pharmaceutical and medical device companies, a frequent medical translation need is labeling. Translating labeling and instructions is either an absolute requirement in order to sell their product in a specific target market, or else it is an important step in minimizing risk and liability. Most EU members require that medical device labels be translated into their official language, though some accept labeling in English as long as the device is exclusively for professional use. In practice the majority of medical device companies translate their labeling and instructions for use (IFUs) into the official languages of all EU countries in order to reduce risk and as a marketing tool. Similarly, pharmaceutical companies need to translate medical labeling  and information on prescription medication like warnings, side effects, and frequency of use. These labels and instructions must be translated into dozens of languages, and can present a significant medical translation expense for life sciences companies.

In order to lower these medical translation expenses, some life sciences companies have turned to machine translation or cheap translators. This is a big no-no. Medical translation errors in labeling or IFUs could lead to regulatory or civil liability and are a leading cause of medical device recalls. Labeling translation requires absolute accuracy and precision. Machine translation is not yet accurate enough to translate the medical terminology used in medical labels. Likewise, very cheap translation companies either use inexperienced translators or don’t perform critical QA steps like back translations, in-country review, or readability testing. These steps go beyond standard translation industry QA like proofreading and review, and are rarely included in the standard rates that discount vendors are providing. Not only could the quality be an issue, you also could end up paying much more for the medical translation that you realized. Given the risk and liability involved in medical translation, deliverables must be absolutely error free. And the best way to ensure error-free labeling translations is turning to an experienced, ISO-certified medical translation company.