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 medical device translation 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. Clients include 77 Elektronika, 3DHISTECH, B.Well Swiss, Carl Zeiss Vision, Roche, Medasense, and dicomLAB Dental.
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Why Medical Device Translation Is Different
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. An error in an IFU is not a quality issue. In a safety-critical device, it is a patient safety issue.
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. 24 languages are required for full EU market coverage.
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.
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. Labelling translation is handled with awareness of physical space constraints and text expansion requirements.
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 We Translate For
We regularly translate documentation 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
Clients We Have Supported
77 Elektronika — 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, Hungarian, Italian, Japanese, Korean, Latvian, Lithuanian, Macedonian, Norwegian, Polish, Portuguese, Romanian, Russian,
Serbian, Slovak, Slovenian, Spanish, Swedish, and Turkish. 52 projects, 299 individual translation jobs. Cybersecurity documentation, software update summaries, InDesign-format user manuals, and quick reference guides included.
3DHISTECH — digital pathology scanner documentation, CaseManager user guides, and imaging system materials translated from English into Danish, Dutch, French, German,
Hungarian, Italian, Norwegian, Polish, Russian, Spanish, and Turkish — and from Hungarian into
Korean. 57 projects, 107 jobs. Documentation delivered in tracked-changes Word format and
InDesign IDML format.
B.Well Swiss — 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, Hungarian, Italian, Latvian,
Lithuanian, Norwegian, Persian, Polish, Romanian, Russian, Serbian, Slovak, Spanish, and Swedish.
Content delivered in structured Excel files mapped to product model codes. 94 projects, 183 jobs.
Carl Zeiss Vision — ophthalmic and optical healthcare device documentation and clinical
communication translated and interpreted across English, French, German, Hungarian, Italian,
Portuguese, and Spanish. 16 projects, 52 jobs including simultaneous interpreting for European
Works Council meetings and clinical business events.
Schrack Seconet — healthcare-call system and hospital safety system documentation
translated via XML and SDLXLIFF localization packages across English, German, Hungarian, Italian, and Polish. 150 projects — one of our longest ongoing medical environment documentation relationships.
Roche — diagnostics and regulated healthcare documentation, pharmaceutical contracts, and certified documents translated across Croatian, English, French, German, and Hungarian. 97 projects.
Medical-Technology — medical device manuals, brochures, and quality documentation
translated from English and Italian into French, German, Portuguese, and Spanish — including
structured quality manual content.
CAIRE Medical — 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.
dicomLAB Dental — dental implant planning and guided surgery software documentation and
device labelling translated from English and Hungarian into Danish, Dutch, French, German, Italian, and Spanish. Software localization (i18n Excel files) included alongside traditional documentation.
Hoya Lens — optical lens product documentation, marketing materials, and distribution agreements translated across Arabic, English, French, and Russian.
Medasense — medical device technical documentation for a pain monitoring device
manufacturer translated from English into French, German, Italian, Portuguese, and Spanish — six-language simultaneous program.
C.S. Medical — user manuals and multilingual product documentation translated across
Chinese, English, French, German, Hungarian, Romanian, Russian, and Spanish.
Biotek Italy — medical-aesthetic device catalogues and clinical beauty technology product
materials, including consecutive interpreting at specialist events across Italy.
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.
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.
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 For detailed guidance on EU MDR language requirements, see our guide: → Regulatory
Translation Requirements for Medical Device Manufacturers
Quality Process All medical device translation is delivered under our ISO 17100:2015 certified quality process: Translation by a subject-matter qualified translator with a life sciences, biomedical, or clinical
background
Mandatory independent revision by a second qualified linguist — checking accuracy against source, terminology consistency, register, and completeness
Terminology management — device-specific and client-specific glossaries maintained and applied across all projects and all language versions
Translation memory — approved translations from previous IFU versions applied to updated versions, ensuring consistency and reducing the cost of regulatory updates
Certificate of translation available for regulatory submission purposes
Frequently Asked Questions
Can you translate IFUs for submission to a notified body? 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.
Can you handle InDesign-format device documentation? 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.
Can you manage a full 24-language EU IFU program? Yes. We coordinate simultaneous delivery
into all 24 EU official languages from a single workflow, with consistent terminology and a single project management contact.
How do you handle IFU updates between device versions? 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.
Do you provide certified translation for medical device regulatory purposes? Yes. Certificates of
translation with signed declaration, agency stamp, and signature are available at no additional charge.
What non-EU markets can you cover? 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.
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.
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Industry → Regulatory Translation Requirements for Medical Device Manufacturers