Medical Device Translation
Translation of instructions for use, labeling, and technical documentation — with the terminology discipline regulated device content demands, into the languages your target markets require.
5.0 average rating on Google reviews Quotes returned same business day
Certified GSA Schedule Holder - HIPAA-trained staff
- 300+ languages - 24/7 support
- GSA Schedule Holder - NASPO ValuePoint Contract Holder - Trusted by State & Federal Agencies - Serving Major U.S. School Districts
What is medical device translation?
Medical device translation is the specialized translation of device documentation — instructions for use (IFU), labeling, manuals, software interfaces, and technical files — by linguists with medical and technical subject-matter expertise. Under EU MDR, device information must be provided in each target market's official languages, making translation a market-access dependency, not an afterthought.
In device documentation, an error is a hazard and a hold-up
An IFU mistranslation can create a usability hazard in a clinician's hands; a labeling error can stall market access in an entire country. Device documentation carries both patient-safety and regulatory consequences, and it needs translators who understand the technology — plus a process that keeps every term identical across dozens of documents and languages.
Device manufacturers have trusted Taika since 2009
Taika Translations translates regulated device documentation with linguists matched to medical and technical subject matter — 80,000+ projects and over a billion words delivered across 300+ languages, with GSA and NASPO ValuePoint contracts and a 5.0★ Google rating. Every program runs on a device-specific glossary and translation memory, with an NDA available on request.
How device documentation projects run
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Share your document set and markets
Request a quote with your device class, document set, and target markets. Quotes are answered the same business day, with an NDA first if you require one.
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Subject-matter translation + TEP
A translator experienced in medical-technical content translates against your glossary; a second qualified linguist independently edits and proofreads — terminology, figures, and warnings verified against the source.
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Consistent delivery across every language
Deliverables return in your source format, with glossary and translation memory maintained so the next labeling update stays consistent with the last.
What you get
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IFU and labeling specialists
The core regulated deliverables — instructions for use, labeling, and packaging — translated by linguists who work in device content.
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Terminology locked by glossary and TM
A device-specific glossary and translation memory keep every term identical across documents, languages, and future updates.
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TEP on every deliverable
Translation, independent editing, and second-linguist proofreading — the quality process regulated content requires.
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The languages your markets require
300+ languages, covering the official languages your regulatory market list demands.
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Confidential handling
Technical files and pre-market documentation are handled privately, with an NDA signed whenever your organization requires one.
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Timelines aligned to submissions
Quotes are answered the same business day with a firm timeline, so translation never becomes the critical path to launch.
Medical device documentation sits at the intersection of technical precision and patient safety. An instruction-for-use mistranslation can create a usability hazard; a labeling error can hold up market access. Both carry regulatory consequences.
Taika Translations translates the documentation a device carries into every market — instructions for use, labeling and packaging, user and service manuals, software interfaces, and technical and usability files — with translators matched to medical and technical subject matter.
Aligned to market-access requirements
The EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) require the information supplied with a device to be available in the official language(s) of each member state where it is placed on the market. That turns translation into a market-access dependency: a device cannot ship into a country whose language requirements its documentation doesn’t meet.
Taika translates device documentation into the member-state languages your market list requires, with the terminology discipline that regulated technical content demands.
What you can order
- Instructions for use (IFU) and labeling — the core regulated deliverables, across member-state languages.
- Manuals, technical files, and usability documentation — consistent with your source of record.
- Software UI and patient-facing materials — reviewed for readability, not just accuracy.
Every project runs on a device-specific glossary and translation memory so terminology stays consistent across documents, languages, and future updates. Request a quote with your device class, document set, and target markets.
- HIPAA-Trained Staff
- 5.0★ Google Rating
- Trusted by State & Federal Agencies
What we cover
- Instructions for use (IFU)
- Device labeling and packaging
- User and service manuals
- Software and UI strings
- Technical documentation and technical files
- Risk-management and usability files
- Patient-facing materials
Quality & consistency
- Subject-matter translation by a linguist experienced in medical-technical content, against a device-specific glossary
- Independent edit and proofread by a second qualified linguist — terminology, figures, and warnings verified against the source
- Glossary and translation memory maintained across versions; NDA available on request
What clients say
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“Truly exceptional communicators. A real pleasure to work with — everything is done right. AAA+”
Edward · longtime partner
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“Impeccable expertise and a flawless manner of doing business, all topped with a heartwarming attitude.”
Sergey P. · client since 2019
Credentials & registrations
- GSA Schedule Holder
- NASPO ValuePoint
- Veteran-Owned (VOSB)
- SAM.gov Registered
- Meets ISO 17100 · 9001 · 27001
- ATA-Certified Translators
- 5.0★ Google Rating
- HIPAA-Trained Staff
Frequently Asked Questions
What device documents do you translate?
Instructions for use (IFU), device labeling and packaging, user and service manuals, software and UI strings, technical documentation, risk-management and usability files, and patient-facing materials. Tell us the device class and target markets when you request a quote.
Do you support EU MDR and IVDR language requirements?
The EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) require information supplied with a device — including instructions for use and labeling — to be provided in the official language(s) of each member state where the device is sold. Taika translates device documentation into the member-state languages your market access requires; confirm the exact language list for your target countries with your regulatory team.
How do you keep terminology consistent across languages and versions?
Taika builds and maintains a device-specific glossary and translation memory so terms stay consistent across IFUs, labeling, and every documentation update — which matters when a single term appears across dozens of documents and languages.
Who translates device documentation — are they qualified for it?
Projects are assigned to professional linguists matched to medical and technical subject matter, and every translation is independently edited and proofread by a second qualified linguist. We use ATA Certified translators whenever the client or content requires or requests it.
How is confidential pre-market documentation handled?
Technical files, usability studies, and unreleased product documentation move through secure transfer and are handled privately by the assigned team. Taika signs a non-disclosure agreement whenever your organization requires one — raise it when requesting a quote.
Can you handle ongoing labeling and documentation updates?
Yes — because your glossary and translation memory are maintained between projects, each labeling revision or IFU update is translated consistently with everything delivered before it, across every language in your program.
Ready when you are
Prefer to talk? Call +1 830-355-2205 or +1 865-258-7903 — quotes returned same business day.
Reviewed by Artjom Dudarev, Senior Project Manager — updated