Accurate translation of instructions for use, labeling, software, and regulatory submissions for medical devices. Specialist linguists who meet EU MDR and FDA standards across 50+ languages.
Medical device translation carries some of the highest stakes in our field, because patient safety and regulatory approval both depend on it.
Every text, from a user manual to a software interface, has to be accurate, culturally appropriate, and compliant with the standards of each market. Our medical translation specialists pair deep clinical terminology with an understanding of how devices are actually used at the bedside.
A mistranslated instruction or safety warning can put a patient at risk and stall a product launch, so we treat every device project with the rigor regulators expect.
Linguists who know EU MDR and FDA requirements handle your instructions for use, labeling, and regulatory files, and we can add certified document translation whenever an authority asks for it. For companion drug-device products, our pharmaceutical translation team keeps terminology consistent across the full dossier.
Instructions and interface text for MRI, CT, and X-ray systems, translated so clinicians operate complex equipment safely in their own language.
Setup guides, warnings, and app strings for heart-rate monitors, glucose sensors, and fitness trackers that patients use at home.
Use, maintenance, and patient-care documentation for surgical instruments, pacemakers, stents, and prosthetics, where precision is not optional.
Instructions for use, on-product labeling, and safety warnings prepared to meet the reading level and legal wording each market requires.
Device firmware, companion apps, and on-screen menus localized so the interface reads naturally to every operator and end user.
Technical files, clinical evaluation reports, and submission documents translated to the terminology reviewers at the EMA, FDA, and notified bodies expect.
“Reliable, trustworthy and customer-centric This is the summation of Michael, Suzy and their team of translators. I have worked with them for over a year, and they have been my translation service for advertising in many European languages - from Swedish to +”
Google review (INTL) , 6 years ago
“Highly professional and meticulous work. They truly listened to my needs and communicated very responsively. Very satisfied with the work done.”
Google review (FR) , 2 months ago
“It is a real pleasure to work with the BeTranslated team who has been very professional, flexible and responsive during all projects.”
Google review (INTL) , 3 years ago
We cover diagnostic equipment, wearable health monitors, surgical instruments, implantable devices, and laboratory systems. That includes instructions for use, labeling, software interfaces, safety warnings, and regulatory submissions.
Yes. Our medical device linguists work to the wording and reading-level standards set by EU MDR and the FDA, and they align terminology with the requirements of notified bodies and other regulators.
We localize firmware messages, companion app content, and on-screen menus, keeping strings within length limits and consistent with the printed manual and labeling.
We build a project glossary and translation memory for each client, so a term used in the manual, the labeling, and the regulatory file reads the same way every time. That also speeds up updates to later versions.
When an authority requires it, we deliver certified translation for regulators with a signed statement of accuracy. Tell us the target market and we will confirm exactly what form of certification applies.
Send us the device documentation, target markets, and any regulatory deadlines. We will match the right medical linguist, confirm certification needs, and return a clear quote as quickly as possible.
