Translation of IFUs for Medical Devices

IFUs (Instructions for Use) for medical devices are a vital document for the medical industry. They contain detailed information on how to use and maintain a certain device, instrument, software or in-vitro diagnostics device (IVD device).

Professionals in the healthcare industry, doctors, nurses and medical technicians are the target audience employing IFUs, as they handle the equipment or device in a hospital or clinical setting.

Therefore, professionals rather than patients/ lay people should understand the language used in IFUs .

On the contrary, in the case of digital medical devices for remote or home-use by lay patients, the language employed in IFUs is simple, straight-forward and with no difficult medical jargon.

Translation of IFUs requires acuracy, precision and consistency of terminology.

Specifically, knowledge of the certain medical sub-fields combined with high quality control standards in translation will achieve these imperatives.

Last but not least, at the end of the translation process Paspartu will issue a Certificate of Translation Accuracy, to attest to the above. This certificate is usually required by auditors or regulatory bodies.

Dedicated medical translation team covering 40 languages

Our medical team at Paspartu can help you solve all challenges related to the translation and localization of your IFUs in as many as 40 European and Asian languages, through a complete range of linguistic solutions:

  • Linguistic consulting and simplifying your English language source file to the level required for lay-use in case of home-use digital medical devices. Meaning that, IFUs should be accessible to the understanding of a 4th grade graduate.

  • Translation and localization of IFUs with challenging medical jargon, meant for hospital use by medical professionals

  • Quality Check for existing translations

  • Review by Subject Matter Experts of existing translations

  • Terminology management and glossary creation. We produce and mantain multilingual glossaries with your key terminology, so that your key terms are consistently used across all your communication channels

  • Back translation for highly sensitive and challenging documents to ensure that translation closely reflects the original

  • Desk Top Publishing=> recreating your initial source language formatting into all your target languages

  • File Versions Management=> the new MDR requires that IFUs are updated according to the new regulation, so translations of updated files should be made available as well

IFUs translation should meet high standards of precision, accuracy and clarity of terminology

IFUs play a vital role in the proper and safe use of a medical device. Therefore, IFUs translation should only be handled by experienced native medical translators and Subject Matter Experts.

Moreover, translation of IFUs for medical devices should comply with strict confidentiality & security requirements that only professional, 17100 ISO certified translation agencies can secure.

Interested to learn about the history of medical translation? Check our LinkedIn post

Curious how we solved medical translation challenges for key players in your field? See here

Get in touch with our dedicated Medical Translation Team –  for a free quotation/ translation sample!

Translation of Medical & Pharmaceutical Documents