IFU Translation

  • Our translators are industry experts
  • We exclusively use native speakers
  • Innovative translation software
  • ISO 9001, ISO 17100, ISO 18587 certified
  • Over 160 languages
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IFU translation for optimal user-friendliness

Instructions for Use (IFU) documents are the user manuals included with medical devices and pharmaceutical products. CE marking is mandatory for the introduction of your medical product in the European market. A crucial part of this marking is the translation of all required documents into the language(s) of the country. This includes the Instruction for Use documentation.


The steps to a multilingual user manual 

You have your IFU master document ready. Now is the time to introduce your medical device in several countries simultaneously. Thanks to our project managers’ strict coordination and management, you can be sure of a timely and good translation. Sometimes we provide up to 20 languages at the same time. Besides translations to Dutch, English, French, German, and Spanish, our translation agency can also provide you with translation into Arabic, Russian, Japanese, and Chinese.


Accurate and precise translation of user manuals 

A typo on your website is annoying. An error in a user manual, however, can have unpleasant consequences. In our working method for translating IFU, we have therefore included several checkpoints. After an experienced medical translator has finished the translation, a proofreader goes through the entire translation in search of errors and areas for improvement. And if the human eye still misses a mistake, our translation software will definitely spot it during the final checks. The result: a multilingual user manual that ensures that everyone can safely use your product.


Translation according to EMA guidelines 

The quality of a medical-pharmaceutical product is determined by the European regulations of the European Medicines Agency (EMA). For example, the EMA publishes templates that the IFU must follow. This applies to product characteristics as well as labeling and packaging. Examples include content requirements, standard headings and the structure and layout of an IFU. The guidelines are applicable in all official countries within the EU (plus Iceland and Norway). Our medical translators know the EMA guidelines and translate your IFU in accordance with these international rules.


Wondering what we can do for you? Feel free to contact us.


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