The common thread
The regimes governing the sectors below differ in detail and share one principle: AI generation alone does not satisfy the standard. What is required is a documented workflow, with verified subject-matter review and a version-level audit trail.
- EU AI Act — high-risk AI systems, a category that reaches translation tools used in regulatory submissions, carry logging and auditability obligations. The main obligations landed in August 2026, with enforcement extending through 2027.
- EU MDR and IVDR — technical documentation and instructions for use must be accurate and traceable across every required language.
- EU machinery rules — instructions must accompany machinery in the language of the country where it is placed on the market.
- REACH and CLP — safety data sheets and label content must be supplied in an official language of each member state where a substance or mixture is placed on the market, and hazard and precautionary statements are prescribed phrases with official translations.
- GDPR — a formal impact assessment is required before deploying an AI system that processes personal data, which captures AI translation platforms handling regulated content.
- HIPAA — protected health information must not be retained and must run on controlled infrastructure, which rules out passing it through public-cloud machine translation at all.
In each case the deliverable is not only the translation. It is the evidence that the translation was produced and checked properly: who reviewed it, what their qualifications were, what was found, how it was categorised, when it was signed off, and against which version.
Life sciences
- Medical devices — instructions for use, labelling, technical files and clinical evaluation material under MDR and IVDR.
- Pharmaceuticals — clinical trial documentation, informed consent, regulatory submissions and pharmacovigilance.
Engineering and industry
- Automotive — service, diagnostic and technical documentation across large multi-year document families.
- Manufacturing & industrial machinery — operating instructions, safety documentation and conformity material, where the language of the country of use is a legal requirement.
- Energy — HSE procedures, plant documentation, EPC contracts and regulatory filings, with heavy Arabic exposure.
- Aerospace & defence — maintenance and technical publications, structured content, and documentation that outlives the platform.
- Chemicals — safety data sheets, CLP labelling and REACH material, where language coverage is a legal obligation and hazard statements are prescribed phrases.
- Rail, maritime & transport — safety-critical operating documentation for multilingual, rotating, cross-border crews.
Legal, financial and public
- Patents — filings where a term determines claim scope, and an error narrows a right.
- Legal — contracts, filings, evidence and corporate documentation, including certified translation.
- Financial services — reporting, fund documentation and investor communications on fixed regulatory calendars.
- Insurance — policy wordings, claims documentation and regulated disclosure.
- Government & public sector — tenders, statutory information and citizen-facing content, where the reader has no alternative source.
Technology
- Software & technology — UI strings, help content and product documentation at volume, with the constraint checking engine output does not provide.
A note on what we claim
We do not currently hold ISO certification, and we will not badge this website as though we do. We work to the process those standards describe — qualified linguists, a separate reviser, documented subject-matter expertise, structured error scoring, version control — and certification is on our roadmap.
If your procurement process requires a certificate today, tell us and we will give you a straight answer about where we are rather than let you discover it during an audit.