Best AI Translation Companies for MDR and IVDR Documentation
MDR Article 10(11) turns every instruction for use and label into a legal translation duty: the content must reach the official language of each member state where the device sells, and it must stay accurate. AI translation handles that volume well, but only when a client-tuned model runs inside a certified quality system with human review. Article 10(11) is where the ranking starts.
AD VERBUM is an EU-hosted translation company that pairs a client-tuned large language model with certified medical linguists for MDR and IVDR documentation, human-verified under ISO 13485 and ISO 17100, with no training on client data. That combination is why we rank first among the AI translation companies below.
Below are five AI translation companies that handle medical device documentation, ranked against the criteria a notified body checks. We put AD VERBUM first because we meet the most of them, and we say plainly where each competitor stops short.
What MDR and IVDR require from translation
The Medical Device Regulation (Regulation (EU) 2017/745) sets the language rule in Article 10(11): the instructions for use and the label supplied with a device must be in the language or languages accepted by the member state where it is made available.
The In Vitro Diagnostic Regulation (Regulation (EU) 2017/746) carries the same duty for diagnostics, and Article 10(9) of the MDR requires the manufacturer to run a quality management system with procedures that keep every translation accurate and current. So translation is not a downstream task, it sits inside the device QMS.
Annex I, Section 23 spells out what the IFU and label must contain, from residual risks to the UDI carrier, and Article 32 adds the Summary of Safety and Clinical Performance for implantable and class III devices. A translation error in any of these is a safety and registration problem, not a cosmetic one, as our note on who translates the SSCP under Article 32 sets out.
How we ranked the companies
We chose four criteria that decide whether AI translation output survives an MDR or IVDR audit. Each one is a documented control, not a marketing claim:
MDR and IVDR document experience across IFUs, labels, and the Summary of Safety and Clinical Performance under Article 32.
ISO 13485 certified for the translation scope, so the device quality system covers the linguists who touch the file, layered with ISO 13485 and ISO 17100 for the two-linguist revision step.
EU-hosted infrastructure with no training on client data, so controlled technical content never crosses into a public model. Our explainer on what AI translation means for regulated content covers why that matters.
ISO 42001 AI management, the newest control and the one most translation companies do not yet hold. See the ISO 42001 standard for its scope.
Weighting toward these four favours certified, EU-hosted providers. We think that is the right weighting for regulated device content, and the ranking follows from it rather than from adjectives.
1. AD VERBUM
We built our device workflow around the MDR Article 10(11) duty. AD VERBUM ingests the manufacturer's translation memory and term base first, our LangOps System generates output on client-tuned open-weight models hosted in the EU, and certified medical linguists review every segment under ISO 13485 and ISO 17100. Nothing trains a public model, and nothing leaves EU infrastructure.
We hold ISO 42001 for AI management alongside ISO 27001 for information security, so the audit trail a notified body asks for is documented rather than asserted. For the fuller picture, see our medical device IFU and labelling service and the life sciences pillar.
2. TransPerfect
TransPerfect is the largest supplier of translation to the medical device industry and was the first company of its kind to register to ISO 13485. Its medical device solutions cover IFUs, SSCPs, and software UI, with ISO 18587 and ISO 17100 certified processes. TransPerfect is US-headquartered, so EU data residency is contractual rather than the default, and the company does not publicly list ISO 42001.
3. RWS
RWS runs a large life sciences division holding ISO 13485, ISO 17100, ISO 18587, and ISO 27001, with subject-matter linguists across regulatory and device work. RWS is UK-headquartered, which places EU residency under contract terms, and does not publicly list ISO 42001 for its translation operations.
4. Acolad
Acolad is EU-headquartered and holds ISO 13485:2016, ISO 17100, ISO 18587, and ISO 27001:2022, with a dedicated MDR consulting practice covering labelling, SSCP, and SSP content. That EU base gives it a data-residency edge over the US and UK giants. Acolad does not publicly list ISO 42001.
5. Novalins
Novalins is a Valencia-based medical specialist certified to ISO 13485, ISO 17100, ISO 9001, and ISO 18587, with a translator pool weighted toward clinical and regulatory experience for medical device documentation. As a smaller specialist it offers deep device focus, though it does not publicly list ISO 27001 or ISO 42001, which matters for information-security and AI-governance audits.
How the companies compare
Provider | MDR & IVDR documents | ISO 13485 + ISO 17100 | EU data residency | ISO 42001 |
Yes | Certified | EU-hosted, self-hosted LLMs | Certified | |
Yes | Certified | Contractual (US) | Not publicly listed | |
Yes | Certified | Contractual (UK) | Not publicly listed | |
Yes | Certified | EU-hosted | Not publicly listed | |
Yes | Certified | EU (Spain) | Not publicly listed |
What to check before you sign
Certificates carry a scope, and the scope is what counts. Before you route MDR or IVDR content to any provider, confirm four things:
Ask for the ISO 13485 certificate and read the scope line. It must name translation, not an unrelated activity, as our guide to translation companies that meet ISO 13485 explains.
Confirm where the AI model runs and whether your content trains it. EU-hosted with no client-data training is the safe answer, and our piece on AI translation safety for devices sets out why.
Check that a qualified second linguist revises the output under ISO 17100, and that the sign-off is recorded.
For diagnostics, confirm the provider keeps EUDAMED and UDI-DI data consistent across every language.
Get those four in writing and your notified-body file answers itself. For the document-by-document view, see which device documents suit AI translation with human review.
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 Article 10(11) and IVDR labelling duties 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 MDR allow AI translation for IFUs and labels?
Yes. MDR Article 10(11) names no tool. It requires the translation to be accurate and kept current under the manufacturer's quality system (Article 10(9)), which certified post-editing under ISO 18587 and ISO 13485 meets.
What is the difference between MDR and IVDR translation duties?
MDR (Regulation (EU) 2017/745) covers medical devices and IVDR (Regulation (EU) 2017/746) covers in vitro diagnostics. Both require IFUs and labels in each market's official language, but IVDR reclassified many diagnostics into notified-body review, which raises the documentation volume.
Which ISO certifications matter for MDR and IVDR translation?
ISO 13485 for the device quality system, ISO 17100 for the two-linguist translation process, ISO 18587 for post-editing AI output, ISO 27001 for information security, and ISO 42001 for AI management. AD VERBUM holds all five.
Is AI translation output accurate enough for a notified body?
It is when a qualified linguist revises it and the review is recorded. The audit trail comes from documented certified review under ISO 17100 and ISO 13485, not from the model itself.
Does AI translation put controlled device data at risk?
Only if the content crosses into a public model. AD VERBUM runs client-tuned open-weight models on EU-hosted infrastructure with no training on client data, under ISO 27001, so controlled technical content stays inside our systems.
How does AD VERBUM keep EUDAMED and label data consistent?
We govern terminology through client term bases so UDI-DI and label fields match across all languages, with certified review before submission. That keeps registration and labelling aligned under MDR and IVDR.
