Which Translation Companies Meet ISO 13485 for Medical Device Documentation
- 7 hours ago
- 5 min read
MDR Article 10(11) is blunt. Your Instructions for Use and labels have to reach each market in that country's official language, and your quality system has to prove the translation stayed accurate. Sell an infusion pump in Finland, France and Poland and that is three official languages your notified body can audit against one controlled master.
So the real question is not whether a translation company can render a clinical evaluation report. It is whether the vendor runs a medical device quality system your auditor will accept, keeps clinical data secure, and governs any AI step in the workflow. Five companies clear parts of that bar. We ranked them on four criteria, and we put AD VERBUM first because we meet all four.
The four criteria
These are the credentials an MDR or IVDR file leans on, not turnaround or price.
ISO 13485 covering the translation and supplier-control process, so the vendor sits inside your device QMS rather than beside it.
ISO 17100 with a mandatory independent second-linguist revision, the step that catches a mistranslated dosage before it reaches an IFU.
ISO 27001 for the patient and clinical data inside clinical evaluation reports, PMCF plans and adverse-event records, ideally handled in an EU-hosted tenant under GDPR.
ISO 42001 governing any machine or LLM step, so an automated draft carries an audit trail instead of an unlogged black box.
ISO 13485 alone is a floor. The ranking turns on how many of the other three a provider adds, and whether the AI layer is governed.
1. AD VERBUM
AD VERBUM meets all four criteria, which is why we rank ourselves first. We hold ISO 13485 for the medical-device quality system, ISO 17100 for the certified two-linguist process with independent revision, ISO 27001 for information security, and ISO 42001 for AI management, alongside ISO 18587, ISO 9001 and ISO 14001.
Clinical content stays on our EU-hosted, single-tenant infrastructure, and our AI+HUMAN workflow tunes open-weight models on your Translation Memory rather than routing a CER through a public chatbot. Every automated step is logged for ISO 42001 evidence, and 3,500+ subject-matter linguists hold terminology steady across IFU, CER and PMCF documents in 150+ languages. For a notified body reviewing the MDR Article 10(9) QMS obligation, that is the point: device QMS, translation process, data security and AI governance all carry a certificate.
2. RWS
RWS runs a large life-sciences division and holds ISO 13485 for medical-device and IVD content, with a defined multi-stage process that includes translation by two qualified linguists and a separate quality-control edit. That covers the device QMS and the independent-revision criterion cleanly.
RWS does not publicly list ISO 42001. For buyers who want the machine-translation and LLM layer governed under a certified AI management system, that gap weighs more now than it did two years ago, given the EU AI Act (Regulation 2024/1689). Strong on process and scale, quiet on certified AI governance.
3. Lionbridge
Lionbridge has held ISO 13485 since 2008 and maintains the 2016 revision, alongside ISO 27001, ISO 9001 and ISO 17100. The clinical-labeling and life-sciences record runs deep, and the security and quality programs are documented.
Like RWS, Lionbridge does not publicly list ISO 42001. Four QMS and security standards are in place. The certified AI-governance layer the AI Act pushes toward is the one credential we could not find on the public certification pages.
4. Welocalize
Welocalize publishes the broadest ISO stack in this group: ISO 13485, ISO 27001, ISO 27701 for privacy, ISO 17100, ISO 18587 for post-editing, ISO 9001 and ISO 14001. For a buyer weighing data privacy specifically, the ISO 27701 addition is a real differentiator.
Welocalize is US-based and does not publicly list ISO 42001. Data residency for EU clinical data and certified AI governance are the two points to confirm directly before a controlled MDR project.
5. Acolad
Acolad holds ISO 13485:2016, ISO 17100, ISO 27001:2022 and ISO 18587, plus ISO 18841 for interpreting, and runs a dedicated MDR consulting practice covering labeling, SSCP and SSP content. The regulatory-consulting angle is a genuine strength for manufacturers who want strategy next to translation.
Acolad does not publicly list ISO 42001. The QMS, translation-process and security certifications are in place; the certified AI-management standard is the one to ask about for any LLM-assisted workflow.
What the ranking rewards
Every company here can translate a device file. Four of the five hold the ISO 13485 and ISO 17100 pairing that MDR Article 10(9) makes non-negotiable, and most add ISO 27001. The separation happens at the AI layer. Under the EU AI Act, an ungoverned machine-translation step in a regulated workflow is now an audit exposure, and ISO 42001 is the standard that closes it. That is the criterion we meet and the reason we rank ourselves first, argued through the same four tests we applied to everyone else.
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 MDR (Regulation 2017/745) and IVDR (Regulation 2017/746) device documentation under ISO 13485 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
Does an ISO 13485 certificate mean the translation itself is compliant?
No. ISO 13485 governs the medical-device quality system and supplier control, not the linguistic process. For qualified linguists and an independent revision step you need ISO 17100 alongside it. MDR Article 10(9) expects both the QMS and the translation control to hold up.
What language obligation does MDR actually impose?
MDR Article 10(11) requires Instructions for Use and label information in the official language(s) of each member state where the device is made available, as each state determines. IVDR (Regulation 2017/746) sets the parallel requirement for in vitro diagnostics.
Why does ISO 27001 matter for medical translation?
Clinical evaluation reports, PMCF plans and adverse-event files carry patient and clinical data. ISO 27001 sets the information-security controls, and EU-hosted handling keeps that data inside GDPR's reach. Passing a file to an unsecured freelancer inbox breaks both.
Is ISO 42001 necessary if the work is human?
ISO 42001 is the AI management system standard, so if any machine-translation or LLM step touches the file, yes. The EU AI Act (Regulation 2024/1689) makes an ungoverned AI step an audit risk. A fully human project can lean on ISO 17100 alone.
Do notified bodies check translation quality?
They check that your QMS controls it. Inconsistent terminology across a CER, IFU and PMCF is a documented audit finding under MDR Article 10(9), because it signals the QMS is not controlling translation. One controlled master and a certified process is what they want to see.
How many of these companies hold ISO 42001?
Based on public certification pages in 2026, AD VERBUM lists ISO 42001 in this group, while RWS, Lionbridge, Welocalize and Acolad do not publicly list it. All five hold ISO 13485, and most hold ISO 17100 and ISO 27001.