Medical Device Translation Services
Accurate, regulation-ready medical device translation for manufacturers selling into global markets. The Translation Company is a women-owned (WBENC-certified) US firm that has translated medical device content since 2005 — instructions for use, labeling, and device software — in the languages EU MDR, IVDR, and other authorities require. For a device, a mistranslated instruction or warning is a safety and compliance risk, not a cosmetic one.
Operating to ISO 9001 and ISO 17100 standards · Women-owned (WBENC) · Serving regulated teams since 2005 · Last updated June 2026
Book a consultation with our CEO, Camila Saunier — a working session about your program, not a sales pitch.
Why medical device translation is different
Medical devices include everything from a tongue depressor to a CAT scan machine. A medical device is any instrument used to diagnose, prevent, or treat a condition without changing the body’s chemistry — which is what distinguishes devices from pharmaceuticals. Their development combines technology and medicine, and because they are sold across borders, medical device translation is essential to getting them to market. It is also unforgiving: an incorrect translation in an instruction for use or a warning label can cause a real-world error, fail an audit, or cost a manufacturer dearly. That is why every project needs linguists who genuinely understand the device and its terminology.
Medical device documents we translate
We translate the full technical and commercial documentation set for device manufacturers:
- Instructions for use (IFUs) and electronic IFUs (eIFUs)
- Labeling, packaging, and Unique Device Identification (UDI) content
- Device software, user-interface strings, and on-screen messages
- Technical files, design dossiers, and declarations of conformity
- Clinical evaluation reports and risk-management documentation
- Quality and manufacturing SOPs
- Patents, research documentation, and regulatory submissions
- Marketing materials and training content
EU MDR, IVDR, and FDA compliance
Selling a device internationally means meeting strict, language-specific rules. Under the EU Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR), instructions for use and labeling generally have to be provided in the official language(s) of every member state where the device is made available — often more than two dozen languages. We also align to FDA expectations, ISO 13485 (medical device quality management), and ISO 14971 risk management, and we provide a signed certificate of accuracy where a notified body or regulator requires one. This is the regulatory backbone the topic demands — not a trade-association footnote.
Built for device manufacturers
When a device is updated, replicated, or rolled out to a new market, its documentation has to be translated accurately and consistently the first time. We build and enforce a device terminology glossary, keep wording aligned across IFUs, labels, and software, and scale to the full set of EU and global languages a launch requires — without dropping the second-linguist review. One accountable partner manages the entire language workstream, from technical file to translated label.
Why device manufacturers choose us
- Women-owned and WBENC-certified. A real advantage for medical device supplier-diversity programs.
- Principal-level accountability. You deal with ownership, not a rotating account manager, and qualified buyers can speak with our CEO directly.
- Human expertise, AI used with judgment. Technology assists; a subject-matter linguist translates and a second reviews. Confidential technical files are never pushed through public machine-translation tools.
- Quality you can document. Processes that operate to ISO 9001 and ISO 17100 standards, with a certificate of accuracy on request.
- Faster turnaround. We consistently deliver 30–50% faster than the industry standard, without skipping review.
How the EU language rules work in practice
The hardest part of medical device translation is often not the languages themselves; it is that there is no single EU language rule. Under EU MDR Article 10, instructions for use and labeling must be provided in the official language(s) that each member state determines for devices made available on its territory — so a device sold across the EU can require well over twenty languages, and the requirement can differ for layperson content versus professional-use content. Going electronic does not change this: under the eIFU regulation (Commission Implementing Regulation (EU) 2021/2226), an electronic instruction for use still has to be available in each accepted official language. We help you map the exact language set for your target markets, keep wording aligned across the IFU, label, and user interface, and update every language together when a technical file changes — so a labeling revision does not leave one market out of date.
Frequently asked questions
What languages does EU MDR require?
Generally the official language(s) of each EU member state where the device is sold, which can mean translating IFUs and labeling into more than 20 languages. We help you map the exact set for your markets.
Do instructions for use need certified translation?
Regulators and notified bodies require accurate, complete IFU and labeling translations, and many submissions call for a certificate of accuracy. We provide one whenever it is required.
Do you work to ISO 13485?
Yes. Our processes operate to ISO 9001 and ISO 17100, and we align to ISO 13485 and ISO 14971 expectations for device content.
Can you translate device software and UI strings?
Yes. We localize on-screen messages, menus, and user-interface strings alongside the IFU, keeping terminology consistent across the device and its documentation.
Which languages do you cover?
The languages your markets and regulators require, across Europe, Asia, the Middle East, and the Americas, plus many more.
Explore related services
- Medical & life sciences translation — our full medical translation practice.
- Pharmaceutical translation — labels, SmPCs, submissions, and pharmacovigilance.
- Clinical trial translation — protocols, ICFs, CRFs, and linguistic validation.
Talk with us about your device documentation
Start with a conversation, not a price tag. Book a complimentary strategy session with our CEO, Camila Saunier, best suited to device manufacturers looking for a long-term partner. Have an IFU or technical file ready? Email [email protected] or call 800.725.6498.