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Medical Device Translation

Professional Medical Device Translation for Manufacturers and Distributors

Business Team Translations translates documentation for medical device manufacturers, diagnostics companies, digital pathology and imaging system developers, health monitoring product suppliers, respiratory and oxygen therapy device companies, optical healthcare organizations, dental technology firms, and healthcare-call system providers.

Our work covers instructions for use, user manuals, technical specifications, software and interface documentation, quality documentation, product brochures, and regulatory materials — across all EU languages and selected non-European markets.

ISO 17100:2015 certified EU MDR & IVDR aligned Clients include 77 Elektronika, 3DHISTECH, B.Well Swiss, Carl Zeiss Vision, Roche, Medasense, and dicomLAB Dental.
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EU MDR requires IFUs and labelling in the official language of every member state where a device is marketed. For pan-European distribution that means 24 languages — a hard regulatory requirement, not a commercial enhancement.

The discipline

Why Medical Device Translation Is Different

An error in an IFU is not a quality issue. In a safety-critical device, it is a patient safety issue.

Medical device documentation is regulatory documentation. An instruction for use is not a product description — it is a legally required document that must be present, in the correct language, before a device can be placed on any market that requires it.

This means that medical device translation carries requirements that general translation does not:

Regulatory compliance

EU MDR (Regulation 2017/745) and EU IVDR (Regulation 2017/746) require that IFUs and labelling are provided in the official language of every EU member state where the device is marketed. This is not optional.

Terminological precision

Medical device terminology is standardized within regulatory frameworks. A term that is technically correct in everyday medical language may not be the term used in the applicable regulatory framework for that market. Translators must know the difference.

Consistency across documentation sets

A device that enters 15 markets has 15 language versions of its IFU, labelling, and related documentation. Every term used in one language version must correspond precisely to its equivalent in all others — this requires active terminology management, not translator judgment on each project.

Subject-matter competence

A linguistically fluent translator without medical device or life sciences background cannot reliably produce the level of precision that regulatory documentation requires. The translator must understand what they are translating.

Our medical device translators have professional or academic backgrounds in life sciences, biomedical engineering, pharmacy, or clinical practice — alongside their language qualifications. They translate medical device documentation because they understand it, not because it was the file that arrived in their inbox.

Document types

What We Translate

Instructions for Use (IFU)

The primary regulatory document for most medical devices. We translate IFUs in full compliance with the content requirements of Annex I, Section 23.4 of EU MDR and equivalent requirements for other markets — covering intended purpose, contraindications, warnings, instructions, performance characteristics, and residual risk information.

User Manuals and Operating Manuals

Complete device manuals for medical professionals, laboratory technicians, and clinical users — including setup, operation, troubleshooting, maintenance, and safety sections.

Labelling and Packaging Content

Device labelling — including all elements required under EU MDR: device name, intended purpose, manufacturer details, UDI, lot and serial information, storage conditions, warnings, and sterilization indicators. Handled with awareness of physical space constraints and text expansion.

Software and Interface Documentation

Software UI strings, embedded help content, system notifications, and interface documentation for medical device software and diagnostic platforms — delivered in the file formats required for integration.

Quality and Regulatory Documentation

Quality manuals, technical file documents, declarations of conformity, clinical evaluation summaries, post-market surveillance documentation, and regulatory correspondence for submission to notified bodies and competent authorities.

Product Brochures and Catalogues

Marketing and sales-support documentation for medical devices — brochures, product catalogues, product comparison materials, and technical data sheets — translated with clinical register for professional audiences.

Summary of Safety and Clinical Performance (SSCP)

The publicly available document required under EU MDR for implantable and Class III devices — translated into the official EU languages relevant to the marketing scope.

Device categories

Device Categories We Translate For

Laboratory diagnostics and in vitro diagnostics (IVD)
Urine analyzers and point-of-care diagnostics
Digital pathology and whole slide imaging systems
Medical imaging and radiology equipment
Health monitoring devices — blood pressure monitors, thermometers, pulse oximeters
Respiratory therapy and oxygen delivery devices
Optical healthcare and ophthalmic devices
Dental implant planning and guided surgery software
Healthcare-call and hospital safety systems
Medical-aesthetic devices and clinical beauty technology
Surgical instruments and device-adjacent clinical products
Track record

Clients We Have Supported

77 Elektronika
Laboratory diagnostics

Urine analyzer, blood glucose monitoring, and laboratory diagnostics device documentation translated from English into 32 languages — including Bulgarian, Chinese, Croatian, Czech, Dutch, Estonian, Finnish, French, German, Greek, Italian, Japanese, Korean, Latvian, Lithuanian, Macedonian, Norwegian, Polish, Portuguese, Romanian, Russian, Serbian, Slovak, Slovenian, Spanish, Swedish, and Turkish. Cybersecurity documentation, software update summaries, InDesign-format user manuals, and quick reference guides included.

32 languages52 projects · 299 jobsInDesign
Schrack Seconet
Healthcare-call systems

Healthcare-call system and hospital safety system documentation translated via XML and SDLXLIFF localization packages across English, German, Italian, and Polish. 150 projects — one of our longest ongoing medical environment documentation relationships.

150 projectsXML · SDLXLIFFLongest-running
3DHISTECH
Digital pathology

Digital pathology scanner documentation, CaseManager user guides, and imaging system materials translated from English into Danish, Dutch, French, German, Italian, Norwegian, Polish, Russian, Spanish, and Turkish — and into Korean. Documentation delivered in tracked-changes Word format and InDesign IDML format.

57 projects · 107 jobs11 languagesTracked changes · IDML
B.Well Swiss
Consumer medical devices

Consumer medical device documentation for blood pressure monitors, thermometers, and health monitoring products translated from English into 22+ languages — including Arabic, Bulgarian, Czech, Danish, Estonian, Finnish, French, Italian, Latvian, Lithuanian, Norwegian, Persian, Polish, Romanian, Russian, Serbian, Slovak, Spanish, and Swedish. Content delivered in structured Excel files mapped to product model codes.

22+ languages94 projects · 183 jobsStructured Excel
Carl Zeiss Vision
Ophthalmic & optical

Ophthalmic and optical healthcare device documentation and clinical communication translated and interpreted across English, French, German, Italian, Portuguese, and Spanish — including simultaneous interpreting for European Works Council meetings and clinical business events.

16 projects · 52 jobsInterpreting included
Roche
Diagnostics · Pharma

Diagnostics and regulated healthcare documentation, pharmaceutical contracts, and certified documents translated across Croatian, English, French, and German. 97 projects.

97 projects5 languages
CAIRE Medical
Respiratory & oxygen therapy

Respiratory and oxygen therapy device technical service manuals translated from English into German and Italian — complex multi-document technical packages including compressor, concentrator, and oxygen therapy system documentation.

EN → DE · ITService manuals
dicomLAB Dental
Dental implant software

Dental implant planning and guided surgery software documentation and device labelling translated from English into Danish, Dutch, French, German, Italian, and Spanish. Software localization (i18n Excel files) included alongside traditional documentation.

6 languagesi18n Excel
Medasense
Pain monitoring devices

Medical device technical documentation for a pain monitoring device manufacturer translated from English into French, German, Italian, Portuguese, and Spanish — a six-language simultaneous program.

6 languagesSimultaneous program
Medical-Technology
Device manuals & QA

Medical device manuals, brochures, and quality documentation translated from English and Italian into French, German, Portuguese, and Spanish — including structured quality manual content.

EN · IT source4 target languages
Hoya Lens
Optical lenses

Optical lens product documentation, marketing materials, and distribution agreements translated across Arabic, English, French, and Russian.

AR · EN · FR · RU
C.S. Medical
Medical devices

User manuals and multilingual product documentation translated across Chinese, English, French, German, Romanian, Russian, and Spanish.

8 languagesUser manuals
Biotek Italy
Medical-aesthetic devices

Medical-aesthetic device catalogues and clinical beauty technology product materials, including consecutive interpreting at specialist events across Italy.

CataloguesConsecutive interpreting
Coverage

Language Coverage for Medical Device Translation

Full EU coverage: we translate into all 24 official EU languages — the full set required for EU-wide market access under EU MDR and IVDR.

All 24 official EU languages
BulgarianCroatianCzechDanishDutchEnglishEstonianFinnishFrenchGermanGreekHungarianIrishItalianLatvianLithuanianMaltesePolishPortugueseRomanianSlovakSlovenianSpanishSwedish
Non-EU markets
Arabic
Gulf Cooperation Council and MENA medical device markets
Chinese (Simplified)
NMPA registration documentation and Chinese market IFUs
Japanese
PMDA submissions and Japanese market device documentation
Russian
CIS market documentation
Turkish
Turkish medical device market documentation
Persian / Farsi
Iranian market documentation

For manufacturers requiring simultaneous delivery into the full EU language set plus non-EU markets, we manage the complete language program from a single coordinated workflow.

Regulatory

EU MDR Compliance and Language Requirements

EU MDR requires IFUs and labelling in the official language(s) of every EU member state where the device is marketed. For pan-European distribution, this means 24 languages — a hard regulatory requirement, not a commercial enhancement.

We translate IFU content in accordance with the content requirements of Annex I, Section 23.4 of EU MDR, ensuring that all mandatory elements are present and accurately translated in every language version.

For manufacturers managing EU MDR compliance, we provide:
Full 24-language IFU translation programs
Translation memory maintenance for efficient version updates
Terminology management across all language versions
Certificate of translation where required by notified body or competent authority
Coordination of language program timelines with conformity assessment schedules
Quality process

Delivered under ISO 17100:2015

All medical device translation is delivered under our ISO 17100:2015 certified quality process:

1
Subject-matter qualified translator

With a life sciences, biomedical, or clinical background.

2
Mandatory independent revision

By a second qualified linguist — checking accuracy against source, terminology consistency, register, and completeness.

3
Terminology management

Device-specific and client-specific glossaries maintained and applied across all projects and all language versions.

4
Translation memory

Approved translations from previous IFU versions applied to updated versions, ensuring consistency and reducing the cost of regulatory updates.

5
Certificate of translation

Available for regulatory submission purposes.

FAQ

Frequently Asked Questions

Yes. We translate IFUs in compliance with EU MDR Annex I, Section 23.4 content requirements and provide certificates of translation where requested by your notified body.

Yes. We translate InDesign (.indd / .idml) device manuals and return print-ready files in the target language. Text expansion for longer target languages is managed in the layout.

Yes. We coordinate simultaneous delivery into all 24 EU official languages from a single workflow, with consistent terminology and a single project management contact.

Through maintained translation memories specific to your device documentation. Where content is unchanged between versions, approved translations are reused automatically — only changed content requires new translation.

Yes. Certificates of translation with signed declaration, agency stamp, and signature are available at no additional charge.

We have documented medical device translation experience in Arabic, Chinese (Simplified), Japanese, Russian, Turkish, and Persian/Farsi, among others. Contact us with your specific market requirements.

Next step

Request a Quote

Send us your IFU, device manual, or device documentation and tell us the target languages and any regulatory submission context. We will prepare a detailed proposal including pricing per language, timeline, and translation memory assessment against any existing documentation.

Need medical device translation?

Send us your documentation and we will prepare a detailed proposal.

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