Medical device industry
IFUs, labeling, technical documentation and EUDAMED data translated by medical specialists — because a notified body reads every word you ship.
An industry where translation is part of the product
A medical device does not clear a European market until its instructions for use, labeling and interface exist in the languages that market requires. Under the EU Medical Device Regulation (MDR — the law governing how devices are approved and sold in Europe), those translations are part of your technical documentation. Notified bodies review them. Regulators can act on errors in them.
That changes what “good enough” means. A mistranslated contraindication is not a typo; it is a nonconformity, and potentially a patient-safety incident.
What device manufacturers translate with us
- Instructions for use (IFUs) and quick-start guides
- Labels and packaging, including symbols and safety phrasing
- EUDAMED data fields — the EU database where device information is registered
- Software interfaces for devices and companion apps
- Clinical evaluation reports and clinical documentation
- QMS documents — the quality-management procedures auditors inspect
- Post-market surveillance reports, field safety notices and recalls
Why generic translation fails here
A generalist translator, or a machine translation engine, produces text that reads smoothly. The problem is what smooth text hides: a “warning” softened into a “note”, a symbol description that does not match the harmonized standard, a dosage step rephrased just enough to be ambiguous. None of these look like errors to someone without a medical background. All of them look like findings to a notified-body reviewer.
Speed pressure makes it worse. Device companies often need 24 or more languages on a fixed submission date, and the temptation is to run everything through an engine and skim the output. Skimming does not catch clinically wrong text that is grammatically perfect.
How our medical practice group works
Link Translation has run a dedicated health-science practice group since the company was founded in 2005. Your files go to native-language translators with medical or life-science backgrounds — people who know why “contraindication” and “precaution” are not interchangeable. They work against your approved term base, and every file receives an independent second review by another specialist before delivery.
Translation memory keeps the package consistent and keeps revision costs proportional: when your IFU changes 8%, you pay for 8%. You get a fixed quote within 24 hours, mapped to the language list your registrations actually require — in Europe, Brazil (ANVISA, the Brazilian health regulator), the US and beyond.
Services that fit this industry
Most device manufacturers combine IFU translation, MDR compliance translation, medical labeling translation, clinical evaluation translation and QMS documentation translation, with terminology management holding the package together. Where lower-risk content genuinely suits machine translation with human post-editing — internal documentation, high-volume support text — we say so in the quote instead of charging human rates for it.
Frequently asked questions
Which documents do medical device companies usually translate?
Instructions for use, labels and packaging, software interfaces, EUDAMED data fields, clinical evaluation reports, QMS procedures and post-market surveillance documentation — usually into every language your market registrations require.
Can machine translation be used for medical device content?
Not for anything a patient, clinician or notified body will read. Machine output can be statistically plausible and clinically wrong, and a wrong warning is a nonconformity. We use technology for translation memory and consistency checks; humans translate and sign off the regulated content.
How do you keep terminology consistent across an entire documentation package?
One term base per client. IFU, labeling, interface and technical file are translated against the same approved terminology, so the device name, warnings and symbols read identically everywhere — which is how auditors expect to see them.
What happens when we revise a document?
Your previous translations live in a translation memory. A revision is quoted on what changed, not the whole document, and the surrounding text is checked so the update does not introduce inconsistencies.