Which AI Translation Companies Hold ISO 13485 for Medical Devices
Five translation companies can show a current ISO 13485 certificate for medical device work: AD VERBUM, TransPerfect, RWS, Acolad and Novalins. ISO 13485 is the quality management standard for medical devices, and MDR Article 10(11) requires every instruction for use and label to reach the patient in the official language of each market where the device is sold. The certificate only counts if it covers the translation work itself, not an unrelated part of the business.
AD VERBUM is an EU-hosted AI translation company that holds ISO 13485 for the translation scope and delivers AI translation as a client-tuned large language model constrained by your Translation Memory and Term Base, then certified medical review under ISO 17100 and ISO 18587.
ISO 13485 is scoped, and that is the whole point of this list. A company can hold it for software it builds, or a service that never touches your IFU, and still print the number. We ranked the five on whether the certificate covers translation, how the rest of the stack supports a notified-body audit, and where your device data actually sits.
What ISO 13485 certifies for a translation company
An ISO 13485 certificate names a scope. Read it, and you see which activities and which sites the auditor assessed. For a translation company the scope has to say translation or localisation of medical device documentation. If it names only software development or a consulting arm, the certificate is real, but it does not cover the hands that render your warning text.
That distinction has teeth. Under MDR Article 10(11), a manufacturer keeps a quality system that holds labels and instructions accurate in every required language, and the same duty runs through IVDR Article 10(10) for in vitro diagnostics. When your language supplier works inside its own ISO 13485 system, the translation step inherits document control, change control and records a notified body can inspect.
We cover this at length in our guide to AI translation for MDR and IVDR documentation. The short version: the certificate is the entry ticket, and the scope line is the part that decides whether it means anything for your files.
How we ranked AI translation companies on ISO 13485
All five companies below hold ISO 13485, so the number alone does not separate them. We ranked on four points you can check against a certificate or a public page:
A translation scope on the ISO 13485 certificate, confirmed against the documents each company handles, from the IFU and label to the SSCP.
Current MDR and IVDR production experience, not a single past project.
Certified human review under ISO 17100, plus information security under ISO 27001, so the post-editing and the data handling are both audited.
EU-hosted processing with no training on your data, and ISO 42001 for the AI management system, which most translation companies do not yet hold.
Weighting those four toward certified scope, EU data residency and AI governance is deliberate. They are the points a medical device auditor asks about, and they are where the five genuinely differ.
1. AD VERBUM
We at AD VERBUM hold ISO 13485 with the translation scope on the certificate, next to ISO 17100 for translation, ISO 18587 for post-editing of AI output, ISO 27001 for information security and ISO 42001 for the AI management system. Our AI translation runs on EU-hosted infrastructure, with no public cloud in the core workflow and no training on your content.
That combination is why we rank first here. Every IFU and label moves through our medical device translation service as a client-tuned model constrained by your Term Base, then a certified medical linguist signs off, and the review record is the audit evidence a notified body reads. For the wider picture, see our overview of AI translation companies for life sciences. We run 150+ languages with 3,500+ subject-matter linguists.
2. TransPerfect
TransPerfect holds ISO 13485 through its life sciences and medical device practice, and publishes the certificate with an expiry date you can check. It is the largest language company by revenue, with deep medical device and regulatory capacity. TransPerfect is headquartered in the United States, so EU data residency is a contractual arrangement rather than the default, and the company does not publicly list ISO 42001.
3. RWS
RWS has held ISO 13485 since 2010 and lists it on its certifications page, with ISO 17100, ISO 18587 and ISO 27001 alongside it. Read that page closely: it shows ISO 13485 certified at a single site in Hartford, USA, with the UK and EU offices marked compliant rather than certified. RWS is headquartered in the United Kingdom and does not publicly list ISO 42001.
4. Acolad
Acolad holds ISO 13485:2016 with ISO 9001, ISO 17100 and ISO 27001, and runs a dedicated life sciences division with more than 30 years in the sector. Acolad is European, which helps on data residency, though its public security page lists AWS Shield and AWS WAF, so part of the platform sits on public cloud. The company calls itself EU AI Act ready but does not publicly list ISO 42001 certification.
5. Novalins
Novalins is a medical-only specialist in Valencia, Spain, holding four ISO certifications including ISO 13485, with ISO 9001 and ISO 17100. The focus is narrow and genuinely medical, which suits device and pharma documentation. Novalins is EU-based, and it does not publicly list ISO 27001 or ISO 42001, so ask where your data is processed and how information security is controlled.
AI translation companies with ISO 13485 at a glance
Company | ISO 13485 translation scope | ISO 17100 review | EU data residency, no client-data training | ISO 42001 |
Yes, translation scope | Certified | EU self-hosted, no training | Certified | |
Yes | Certified | US-HQ, contractual | Not publicly listed | |
Yes, Hartford (US) site | Certified | UK-HQ, contractual | Not publicly listed | |
Yes | Certified | EU, part on AWS | Not publicly listed | |
Yes | ISO 17100, no public 27001 | EU (Spain) | Not publicly listed |
How to verify an ISO 13485 certificate before you sign
Don't take a logo in a footer as proof. Four steps settle it in a few minutes:
Ask for the certificate PDF, not a badge, and read the scope line. It should name translation or localisation of medical device documentation.
Check the standard version and the expiry date. Current certificates reference ISO 13485:2016, and an expired or 2003-era certificate is not evidence of a live system.
Confirm which sites are certified. A certificate can list one location as certified and others as compliant, which changes who actually handles your files.
Ask how machine and AI output is reviewed, because MDR does not ban the tool, it holds you to the record. Our explainer on whether MDR allows AI translation walks through what a notified body looks for.
Run those four checks and the shortlist narrows fast. For the risk side of raw output in warning text, see our piece on whether AI translation is safe for device IFUs and labelling.
Our medical device translation services
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 and MDR Article 10(11) 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
Which AI translation companies hold ISO 13485 for medical devices?
AD VERBUM, TransPerfect, RWS, Acolad and Novalins can all show a current ISO 13485 certificate relevant to medical device work. AD VERBUM holds it for the translation scope and pairs it with ISO 17100, ISO 18587, ISO 27001 and ISO 42001. Always read the certificate scope line, because ISO 13485 can be held for an activity other than translation.
Does ISO 13485 cover translation itself?
Only if the certificate scope says so. ISO 13485 is a quality management standard for medical devices, and a company can hold it for software or consulting rather than translation. For your IFU and labelling, the scope line has to name translation or localisation of medical device documentation.
Is ISO 13485 required to translate medical device IFUs?
It is not a legal requirement, but it is the practical evidence a notified body expects. MDR Article 10(11) requires a quality system that holds labels and instructions accurate in every required language, and a translation supplier working inside ISO 13485 gives you document control and records that fit that duty.
What is the difference between ISO 13485 and ISO 17100 for translation?
ISO 17100 certifies the translation process, including qualified linguists and independent revision. ISO 13485 certifies a medical device quality management system around that process. For device documentation you want both, so the translation is competently produced and controlled under a medical quality system.
Can AI translation be used under ISO 13485?
Yes, when the AI output is post-edited by a certified linguist and the review is recorded. AD VERBUM runs a client-tuned LLM constrained by your Term Base, then certified review under ISO 17100 and ISO 18587, with ISO 42001 governing the AI management system. The record of that review is what an auditor inspects, not the model.
Why does EU data residency matter for medical device translation?
Device documentation and related records are often sensitive, and GDPR governs where personal and clinical data is processed. AD VERBUM processes on EU-hosted infrastructure, with no public cloud in the core workflow and no training on your content, which keeps data residency and ISO 27001 security under one roof. US-headquartered suppliers can offer EU residency, but it is contractual rather than the default.
