for medical devices and digital health
ArtLingua translates MedTech content with qualified linguists, documented workflows, and audit trails structured for notified body and regulatory authority review. Our services cover the full range: from IFU sets and device labeling to regulatory submissions, patient information packages, and digital health applications, including German DiGA submissions.
Rely on us for
IFU, device labeling and technical documentation
Documentation that meets MDR, IVDR, and labeling requirements in every target market.
Translating instructions for use, device labels, technical summaries, and patient information materials in compliance with MDR/IVDR Annex I requirements. All translations are carried out by linguists with documented MedTech expertise and reviewed under a two-person quality process certified to ISO 17100:2015.
Regulatory submissions and clinical documentation
Submissions prepared for notified body and regulatory authority review.
Under MDR Article 10(11), all language versions of your device documentation must comply with the regulation, not just the original. If notified bodies flag discrepancies between language versions, incomplete or inaccurate translations can contribute to a rejected submission or a request for additional information.
Patient information and linguistic Validation
Patient-facing content that's accurate, clear, and supported by documented methodology.
Translating patient information leaflets, informed consent forms, patient guides, and patient-facing IFU sections with a linguist review process tailored to the register and readability requirements of patient-facing content.
For instruments requiring full linguistic validation, covering forward translation, independent back-translation, reconciliation, and regulatory-grade documentation, we work with a research consultancy.
20 years of patient-centered research expertise • 198 countries • 250+ languages
Our partner covers cognitive debriefing, comprehension and health literacy assessment, and FDA/EMA-ready report writing. Together, we deliver end-to-end linguistic validation services, from forward translation through cognitive debriefing to regulatory-ready submission documentation.
Pre-print review
Label translation includes a pre-print review step as part of the standard delivery workflow. Errors in device labels, including missing regulatory symbol translations, mistranslated contraindications, or incorrect UDI-related content, are significantly harder and more expensive to correct after a print run has started.
Consistency across submissions
We translate clinical evaluation reports, performance evaluation reports, technical files, post-market surveillance documentation, and 510(k) submissions. Translation memory and approved terminology are established for each device family to ensure consistency across all documentation, and across submission updates.
For formally validated patient-facing instruments, see our Linguistic Validation service.
Ready to discuss your regulatory documentation, IFU translation, or linguistic validation requirements?
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Frequently Asked Questions
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What does MDR/IVDR actually require from a translation provider?
MDR Article 10(11) requires that all language versions of your device documentation comply with the regulation, not just the original English source. A translation provider working on MedTech content has to be able to demonstrate linguist qualifications, a documented review process, and a traceable audit trail. ArtLingua provides all three as standard on every project. Request a sample compliance documentation package
Can we use our distributors or internal reviewers for translation validation?
Using distributors or in-house staff as reviewers is a common practice that creates a documented compliance risk. ISO 13485 requires qualified personnel for quality-critical tasks. Distributors typically have no documented translation qualifications, carry a commercial conflict of interest, and leave no audit trail. If your quality management system is checked and the qualifications of your reviewer are questioned, distributor reviews can’t support that request. ArtLingua provides qualified, independent review with full documentation at every stage. Learn more about our quality process
What is linguistic validation, and when is it required for medical devices?
Linguistic validation is a documented multi-step process covering forward translation, independent back-translation, reconciliation, and cognitive debriefing with representative patients. It's used to confirm that a translated instrument measures what the original measures, and is typically required for patient-reported outcome instruments, clinical outcome assessments, and informed consent forms used in clinical trials or regulatory submissions. For full linguistic validation services, ArtLingua works with Gibson Research Consultancy, which brings the patient research and cognitive debriefing methodology. Discuss your linguistic validation requirements
What documentation comes with each delivery?
Every delivery includes the linguist's name and qualifications, source and target segment pairs, and a project delivery note. For regulatory submissions and technical files, we provide a full audit trail formatted for notified body or regulatory authority review, including translation memory records and terminology compliance notes. Sample documentation is available before any commitment. Request a sample audit trail