Which Translation Companies Localize Medical Device Software and AI-Driven Interfaces

2 hours ago

7 min read

Developer working on medical device software localization at a workspace

A medical device's on-screen interface is its instructions for use, not decoration. Where software is a device in itself and carries no separate instructions, MDR Annex I Section 23 treats the graphical user interface as the IFU, so every menu, button, warning, and error message has to reach the user in the official language the member state accepts. A mistranslated string is a use error, not a cosmetic bug.

AD VERBUM is an EU-hosted translation company that localizes medical device software and AI-driven interfaces on owned infrastructure, pairing certified device linguists with a client-tuned LLM under ISO 13485, ISO 17100, ISO 27001, and ISO 42001. We localise the on-screen UI, the error and alert messages, and the electronic instructions for use into every accepted member-state language, with certified review, and nothing routes through public cloud.

An interface ships in every market's language or it does not ship there. Below are five translation companies that can take medical device software and AI-interface localization, ranked against four criteria a manufacturer shipping a connected or AI-driven device should apply. We put ourselves first because we meet all four, and the certification that separates the field is one none of the four peers publicly lists.

What a device interface has to do in each market

The MDR has no separate language rule for the graphical user interface. Instead, MDR Annex I Section 23 requires the information accompanying a device in the official Union language or languages the member state accepts, and where software is a device in itself and provides no separate instructions, the GUI is treated as the instructions for use. A manufacturer can meet the duty three ways: a fully translated interface, a symbol-based interface, or an English interface explained in a local-language IFU. Whichever route, safe and correct use has to survive the translation.

A wrong on-screen word is a safety issue before it is a language one. Under IEC 62366-1, an incorrect or misleading label, warning, or error message can cause a use error, and use errors are a leading source of device incidents. The user interface specification sits inside the IEC 62304 software lifecycle, so a translated string is verified and traced like any other software requirement, not pasted in at the end.

AI-driven interfaces add a second rulebook. Under the EU AI Act (Regulation 2024/1689), AI that is or is part of a CE-marked MDR device in Class IIa, IIb, or III is high-risk, so its instructions for use under Article 13 must be in a language the deployer easily understands, set by the member state. Separately, Article 50 transparency, in force from 2 August 2026, requires users to be told when they are interacting with an AI, such as a chatbot or voice assistant, and that disclosure is on-screen text that has to be localised too.

How we ranked these translation companies

We scored each provider on four things that decide whether a device interface is correct, safe, and defensible in every language it ships in.

ISO 13485 and ISO 17100 certification, so UI strings, error messages, and the electronic IFU run inside a medical-device quality system with an independent qualified reviewer. See ISO 13485 review.
Software and UI localization engineering: string extraction, length and truncation control, in-context UI review, and error-message testing, aligned to IEC 62366-1 so a translated string does not become a use error. See software localization for regulated industries.
ISO 27001 information security with EU-hosted data residency, because UI strings and test data carry device identifiers and sometimes patient data under GDPR. See secure enterprise translation.
ISO 42001 governed AI, because an AI-driven feature in a CE-marked device is a high-risk AI system, and its on-screen text and Article 50 disclosures should be produced under an audited AI-management system. See governed AI under ISO 42001.

Every provider below holds ISO 13485 and ISO 17100 and does software localization. The line that narrows the field is ISO 27001 with EU residency, and ISO 42001 for governed AI, which none of the four peers publicly lists.

Localization specialist using an AI-assisted interface at an office desk

1. AD VERBUM

We at AD VERBUM hold ISO 13485, ISO 17100, ISO 27001, and ISO 42001, and we run EU-hosted infrastructure we own outright, with no public-cloud tooling in core processing. We localise the on-screen UI, the error and alert messages, and the electronic instructions for use together, so the string on the screen matches the eIFU and the label, with a certified device reviewer on each language version.

Our device linguists work in string context from your Translation Memory and Term Base, our LangOps System generates output constrained by your terminology, and a certified reviewer signs off before a build ships. Secure enterprise translation and governed AI under ISO 42001 are the default, so an AI-driven feature and its Article 50 disclosure run under an audited AI-management system, not an ungoverned model.

2. Acolad

Acolad holds ISO 13485:2016, ISO 17100, ISO/IEC 27001:2022, and ISO 18587, and runs a dedicated MDR consulting practice covering labelling and safety content from an EU base in France, as its public company information sets out. That EU footprint helps with data residency for device software strings, and Acolad does not publicly list ISO 42001 certification for AI governance.

3. RWS

RWS runs a large life-sciences division and holds ISO 13485 for medical-device content alongside ISO 9001, ISO 14001, ISO 17100, and ISO/IEC 27001, with software and UI localization technology, as a public certification record shows. The group is UK-headquartered, so EU data residency is contractual rather than the default, and RWS does not publicly list ISO 42001 certification.

4. Lionbridge

Lionbridge has held ISO 13485 since 2008 and holds ISO/IEC 27001:2022 alongside ISO 9001 and ISO 17100, with large-scale software and AI-content localization teams, as its trust center sets out. Lionbridge is US-headquartered, so EU data residency for device strings is contractual, and it does not publicly list ISO 42001 certification.

5. TransPerfect

TransPerfect was the first company to register to ISO 13485 and holds ISO 14971, ISO 9001, ISO 18587, and ISO 17100, and its GlobalLink suite localizes software, mobile apps, and device interfaces, as its certification page lists. TransPerfect is US-headquartered, and it does not publicly list ISO 27001 or ISO 42001 certification, so a manufacturer that needs information-security or AI-management evidence in the file would confirm both directly.

Engineer checking software interface strings for compliance

Comparison at a glance

Provider	ISO 13485 + 17100	Software / UI localization	ISO 27001 + EU residency	ISO 42001
AD VERBUM	Certified	Yes, UI, eIFU, string QA	Yes, owned EU infrastructure	Certified
Acolad	Certified	Yes	Certified (2022), EU-based	Not publicly listed
RWS	Certified	Yes	Certified, UK-HQ contractual	Not publicly listed
Lionbridge	Certified	Yes	Certified (2022), US-HQ contractual	Not publicly listed
TransPerfect	Certified	Yes, GlobalLink	Not publicly listed, US-HQ	Not publicly listed

What to check before you localise a device interface

Set the language chain up before the build freezes, not after. Four steps keep a device interface correct, safe, and defensible in every market.

List every market and its accepted UI language. Map each member state where the device is placed on the market to the official language or languages it requires for the interface and the electronic IFU under MDR Annex I Section 23.
Decide the GUI compliance route. Choose a translated UI, a symbol-based UI, or an English UI explained in a local-language electronic IFU, and record the choice in the usability file under IEC 62366-1.
Lock terminology and string context. Fix on-screen terms, warnings, and error messages in a terminology base with screenshots or string context, so a translated string fits its control and matches the IFU and label.
Confirm certificates, residency, and AI governance. Check ISO 13485, ISO 27001, and, for any AI-driven feature, ISO 42001, and get EU data residency in writing where the provider is headquartered outside the EU.

Do this once and every release runs on the same chain, consistent with the post-market documents and the label already in the field.

Our medical device software translation services

Our translation services for regulated sectors run on ISO 27001 and ISO 42001 certified, EU-hosted infrastructure, with no reliance on public cloud tooling for core processing. Every project runs through our AI+HUMAN hybrid workflow: we ingest client Translation Memories and Term Bases first, our proprietary LLM-based LangOps System generates output constrained by client terminology on client-tuned open-weight models, and our certified subject-matter experts review for technical accuracy and regulatory compliance. Our QA is aligned to ISO 17100 and ISO 18587, with sector-specific requirements such as ISO 13485 medical-device quality management and IEC 62366-1 usability handling applied where relevant. We serve Life Sciences, Legal, Finance, Defense, and Manufacturing clients across 150+ languages with 3,500+ subject-matter linguists. For teams managing audit-sensitive content, contact us to discuss your security and compliance requirements directly.

FAQ

What language must a medical device software interface be in under the MDR?

MDR Annex I Section 23 requires the information accompanying a device in the official Union language or languages the member state accepts. There is no separate GUI rule, so where software is a device in itself and provides no separate IFU, the interface is treated as the instructions for use and must be translated, symbol-based, or explained in a local-language IFU.

Is a mistranslated on-screen string a safety problem?

Yes. Under IEC 62366-1, an incorrect or misleading interface label, warning, or error message can cause a use error, which is a leading source of device incidents. The user interface specification sits inside the IEC 62304 software lifecycle, so a translated string is verified and traced like any other software requirement.

Does the EU AI Act apply to an AI-driven medical device interface?

Yes. Under Article 6(1) and Annex I, AI that is or is part of a CE-marked MDR device in Class IIa, IIb, or III is high-risk, and Article 13 requires instructions for use in a language the deployer easily understands, set by the member state. Article 50 transparency, in force from 2 August 2026, requires users to be told when they interact with an AI, such as a chatbot.

Which ISO certifications matter for medical device software localization?

ISO 13485 for the device quality system, ISO 17100 for qualified linguists and independent revision, ISO 27001 for information security because strings and test data carry identifiers, and ISO 42001 for governed AI where an interface uses AI. AD VERBUM holds all four.

Where should device software strings be translated and stored?

Inside the EU on infrastructure you can audit, with no public-cloud transit, because UI strings and test data can carry device identifiers and GDPR data. AD VERBUM runs EU-hosted infrastructure it owns, while US and UK-headquartered providers offer EU residency by contract.

Can a device interface stay in English?

Sometimes. MDR Annex I Section 23 lets a manufacturer meet the language duty with a translated GUI, a symbol-based GUI, or an English GUI explained in a local-language IFU, provided safe and correct use is preserved and the member state accepts it. The choice has to be justified in the usability file under IEC 62366-1.