Which Translation Companies Meet ISO 13485 for Medical Device Translation
- 20 hours ago
- 6 min read
Need an ISO 13485 translation company for medical device work? AD VERBUM leads this list, and the deciding test is narrow. The certificate scope has to name translation or localization services, because a badge that covers something else proves nothing about your instructions for use.
What the certificate actually has to cover
ISO 13485 holds true for any organisation whose work affects medical device quality, and a translation supplier sits inside that chain. The number to look for is on the certificate itself. Its scope statement should read like “provision of translation and localization services for medical device documentation,” not “design and manufacture” of something unrelated. A general ISO 13485:2016 certificate held for a warehouse or a device assembly line does nothing for your IFU.
This matters because your device labelling and instructions for use must appear in the official language of every member state where the device is sold, under MDR Article 10(11). The equivalent obligation for diagnostics sits in the IVDR (Regulation 2017/746). A notified body can ask how those translations were produced and controlled. “Our vendor is ISO 13485 certified” only answers that question if the certificate covers translation.
How we ranked them
We scored providers who genuinely work on medical device documentation, against four tests a device manufacturer can verify:
In-scope ISO 13485:2016. A live certificate whose scope names translation or localization, producible on request, from an accredited body.
MDR and IVDR document depth. Real experience with IFUs, labels, and the EU declaration of conformity across all 24 EU languages, not one or two.
ISO 17100 held alongside. Certified translation process with an independent second linguist, so revision is built in rather than optional.
ISO 27001 and EU hosting. Information security certification, EU data residency, and an audit trail a notified body can follow.
The weighting sits in the criteria, not in adjectives. Every entry below is judged the same way, and each shows what it holds and where it stops short for this use case.
1. AD VERBUM
We hold ISO 13485:2016, ISO 17100, and ISO 27001 as one certified system, with translation inside the scope rather than bolted on. That means an independent second linguist reviews every medical device file, and the source, the target, and the revision sit on EU-hosted, single-tenant infrastructure under ISO 27001.
AD VERBUM also carries ISO 18587 for controlled post-editing, ISO 9001, ISO 14001, and ISO 42001 for AI governance. That last one is the differentiator. None of the four peers below publicly lists ISO 42001, so when machine output touches a warning or an intended-purpose line, we can show a governed workflow, not an unlogged one.
Our medical SME linguists cover 150+ languages, drawn from a pool of 3,500+, and our LangOps System constrains client-tuned open models to your term base. For MDR and IVDR work the practical result is one terminology-controlled pipeline that carries the same wording from label to IFU to EU declaration of conformity.
2. RWS
RWS runs a large life-sciences division with a quality management system certified to ISO 13485 and ISO 9001, alongside ISO 17100. Its multi-stage process uses two qualified linguists plus a separate quality review, and its regulatory experience spans device labelling, manuals, and pharma product information.
The gap for a strict EU brief is delivery footprint. RWS operates globally, so EU-only data residency is arranged per contract rather than assumed by default. RWS does not publicly list ISO 42001, so AI-governance evidence for machine-assisted steps would need to be requested.
3. Lionbridge
Lionbridge has held ISO 13485 since 2008, maintained through the 2016 revision, with ISO 9001:2015 and ISO 17100:2015 on top. It runs a dedicated life-sciences quality management system and handles clinical labelling and regulatory content at scale.
Lionbridge is US-headquartered, so EU data residency is a contractual arrangement rather than the default posture. It does not publicly list ISO 42001, so a manufacturer that wants AI-management evidence in the file would raise it directly.
4. Acolad
Acolad is European-headquartered and lists ISO 13485:2016, ISO 17100:2015, ISO 9001:2015, and ISO/IEC 27001:2022. Its life-sciences workflows align to ICH, EDQM, MedDRA, and EMA, and it offers MDR consulting alongside translation.
That combination gives you ISO 13485 discipline, independent revision under ISO 17100, and certified information security in one place. Acolad does not publicly list ISO 42001, so its position on AI governance for medical content is worth confirming in writing.
5. Welocalize
Welocalize holds a broad stack, ISO 13485:2016, ISO 17100:2015, and ISO 9001:2015, together with ISO 27001 and ISO 18587, backed by a sizeable life-sciences team.
Welocalize is US-headquartered and largely cloud-based, so EU data residency is a configuration to specify rather than a given. It does not publicly list ISO 42001. The stack is deep on process and security, lighter on published AI-management certification.
How to check a scope before you sign
You can settle most of this in one email. Ask the provider for three things:
The current ISO 13485 certificate as a PDF, so you can read the scope line and the accrediting body, not just a logo on a web page.
Confirmation that translation or localization appears in that scope, and that the certificate is in surveillance, not lapsed.
A sample audit trail for one project: who translated, who revised, what terminology was locked, and where the data sat.
If a provider can produce all three within a day, the ISO 13485 claim is real. If the certificate scope covers something other than language services, treat the badge as decoration and keep looking.
Our medical device 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 13485:2016 quality management and MDR (Regulation 2017/745) Article 10(11) language obligations 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 does ISO 13485 certification cover for a translation company?
It covers a quality management system for work that affects medical device quality. For a translation company, the useful certificate names translation or localization in its scope, under ISO 13485:2016. A certificate scoped to an unrelated activity gives no assurance about your device documentation.
Does MDR require the translator to be ISO 13485 certified?
MDR (Regulation 2017/745) Article 10(11) requires device information in the official language of each selling market, but it does not name ISO 13485 for the language supplier. In practice, manufacturers use a certified translation partner as supplier-control evidence, because the notified body can ask how translations were produced and controlled.
What is the difference between ISO 13485 and ISO 17100 for translation?
ISO 13485:2016 is the medical device quality management standard. ISO 17100 is the translation-process standard that requires an independent second linguist to revise the work. Held together, they cover both device-QMS discipline and translation quality, which is why we treat them as a pair.
Does ISO 13485 cover IVDR documents as well?
Yes. The same quality management discipline applies to in-vitro diagnostic documentation under the IVDR (Regulation 2017/746). IVDR IFUs carry the same language obligation, so an in-scope ISO 13485 certificate is just as relevant for diagnostics as for devices.
Is machine translation allowed for medical device content under ISO 13485?
It is, provided the process is controlled and documented. ISO 18587 governs the post-editing of machine translation by qualified linguists. For warning text and intended-purpose statements, the safe route is machine output constrained by a term base and then reviewed by a medical subject-matter expert, with the workflow logged.
How do I verify a provider's ISO 13485 scope?
Ask for the certificate PDF and read the scope line and the accrediting body. Confirm translation or localization is named, and that the certificate is in active surveillance rather than lapsed. A provider that can send the certificate and a sample project audit trail within a day is telling the truth about the claim.
