“I’ve collaborated with this translation agency for a long time and continue to be satisfied with the quality of their services. A dependable partner for multilingual projects.”
Marianne W.
Google review (INTL) , 10 months ago
Medical Translation
Medical Device Translation
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.
Translation for Devices That Patients Depend On
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.
What We Translate for Medical Devices
Diagnostic Equipment Manuals
Instructions and interface text for MRI, CT, and X-ray systems, translated so clinicians operate complex equipment safely in their own language.
Wearable Health Monitors
Setup guides, warnings, and app strings for heart-rate monitors, glucose sensors, and fitness trackers that patients use at home.
Surgical and Implantable Devices
Use, maintenance, and patient-care documentation for surgical instruments, pacemakers, stents, and prosthetics, where precision is not optional.
IFUs, Labeling, and Safety Warnings
Instructions for use, on-product labeling, and safety warnings prepared to meet the reading level and legal wording each market requires.
Software and UI Strings
Device firmware, companion apps, and on-screen menus localized so the interface reads naturally to every operator and end user.
Regulatory Submissions (EU MDR, FDA)
Technical files, clinical evaluation reports, and submission documents translated to the terminology reviewers at the EMA, FDA, and notified bodies expect.
What Our Clients Say
“Very polyvalent and capable office. I got assisted and coached very well by Mike to achieve my business goals by implementing an effective approach to AI in the areas where it could have the most impact for our business. Mike made lots of suggestions and +”
Elias
Google review (SL) , 10 months ago
“Great communication, perfect translations in different languages in a very short notice. I would recommend! We are very pleased, thank you :-)”
Melissa L.
Google review (INTL) , a year ago
Medical Device Translation FAQ
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.
5.0/5.0 from 168 Google Reviews
Medical Device Translation: Talk to a Specialist
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.
Regulatory Expertise
Device Subject Specialists
Confidential Handling