ISO 9001 
ISO 17100 
ISO 18587 LinguaVox provides medical device translation services for medical device manufacturers, distributors, regulatory teams and engineering departments. We manage multilingual projects in more than 150 languages, combining specialist translators, project management, terminology control and review workflows according to what each assignment requires.
Translation for the medical devices sector
Medical device translation brings together three kinds of language at once: engineering, healthcare and regulation. The wording has to stay consistent across instructions for use, labelling, on-screen software and the technical file, because these documents describe the same product and are read together. In the EU, the Medical Device Regulation and the In Vitro Diagnostic Regulation drive much of the demand, as devices generally have to carry instructions and labelling in the national languages of the markets where they are placed. That makes device translation multilingual by default, and consistency across languages a practical requirement rather than a nicety.
For that reason we do not assign work on language pair alone. The document type, the target reader, the destination market, the format and the level of review all shape the workflow.
Documents we translate
Typical documents include instructions for use (IFUs), technical files and design documentation, risk management documents, labelling and packaging text, user interface and software strings, clinical evaluation reports, maintenance manuals, marketing material and training content. Some are read by clinicians, some by technicians and some by patients, so register and terminology shift accordingly. UI strings, in particular, come with length limits and placeholders that have to be respected, which is why we confirm formats and constraints before starting.
Before quoting, we review the files whenever possible to identify non-editable text, tables, screenshots, embedded graphics, software string files, repetitions, multilingual layouts and instructions that should be applied during translation.
Specialist translators and quality control
Projects are assigned to translators with medical device or technical experience and the right language combination. Where the assignment includes bilingual revision, a second qualified linguist checks the translation against the source, and the project manager reviews files, instructions and delivery format before completion. For IFUs and labelling we pay particular attention to consistency between the printed materials and any accompanying software, so the same function is named the same way everywhere.
This supports ISO 17100-based workflows for professional translation. For suitable, lower-risk content, full post-editing of machine translation may be considered, but safety-relevant IFU, labelling and clinical content is normally handled by human translation with revision.
Terminology, software and consistency
A device is described in many places — the IFU, the label, the interface, the technical file, the training material — and a buyer or auditor expects all of them to agree. We manage that with a device-specific termbase and translation memory, handle software strings in their native formats so code and placeholders are preserved, and keep printed and on-screen wording aligned. Planning this from the first language version is far more reliable than reconciling terminology after release.
Languages, software formats and delivery
A single EU device release can involve more than twenty languages at once, so coordination is a large part of the work. We run those languages in parallel, keep terminology and layout consistent across all of them, and deliver on a schedule aligned with the release. Software is handled in its native string formats — including XML, JSON, RESX, PO and XLIFF — so that code, placeholders and length limits are preserved, and we confirm any on-screen character constraints before translation rather than after. IFUs, labels and packaging are often built in InDesign, so we can return translations ready to place and offer proofreading of the laid-out files, with desktop publishing quoted separately. Because the printed materials and the interface have to agree, we apply the same device-specific termbase across both, and across every language version, so the wording a clinician reads on screen matches the wording in the manual. For manufacturers with growing product ranges, this shared terminology and memory also keep new models consistent with the ones already on the market.
Related services
Medical device translation frequently connects with technical translation, software and website localisation, legal and certified translation, desktop publishing for IFUs and packaging, subtitling for training videos and terminology management. The right combination depends on the files and on how the content will be used.
How to request a quote
To prepare an accurate quote, send the files, the language combination, the deadline, the destination markets and the intended use, with any software string files, previous translations, glossaries or style guides. For multilingual releases we can organise staged deliveries, separate files by language and keep a consistent structure across markets, so translation fits your release and regulatory timelines.
Frequently asked questions
Do you translate IFUs and labelling into all required EU languages?
Yes. Devices placed on EU markets generally need instructions and labelling in the national languages concerned. We can coordinate those languages together, with terminology and layout checks agreed in the project scope. We confirm the exact language list with you based on your target markets before starting.
Can you handle device software and user interface strings?
Yes. We translate UI strings in their native formats, respecting length limits, placeholders and variables, and keep on-screen wording consistent with the printed IFU and labelling. Send the string files and any character limits and we will confirm the approach.
How do you keep the IFU, label and software consistent?
We build a device-specific termbase and translation memory and apply it across every document, so a function or warning is named identically in the IFU, on the label and in the interface. This consistency supports clearer review across the device's materials.
Do you translate clinical evaluation reports and technical files?
Yes. We translate clinical evaluation reports, technical and design documentation and risk management documents, assigning translators with the relevant technical and clinical background and adding bilingual revision where the content's risk justifies it.
Can you support both EU (CE) and UK (UKCA) market documentation?
Yes. We can prepare the language versions needed for EU markets and English documentation for the UK, keeping terminology aligned across both. We confirm the required languages and formats per market, though responsibility for regulatory conformity always remains with the manufacturer.
