IFU translation, device labeling, 510(k) and PMA submissions, CE mark documentation, EU MDR Technical Files, UDI labels, and operator manuals — translated by specialists with regulatory and biomedical engineering backgrounds. FDA-compliant. EU MDR-ready. All 24 EU official languages.
EU MDR requires IFUs for all Class I, IIa, IIb, and III devices to be available in the official language(s) of every EU member state where the device is sold. We translate IFUs into all 24 EU official languages simultaneously, with terminology consistency managed across language files.
Response within 2 business hours. Regulatory experience confirmed upfront.
IFU translation is required for market access in every EU member state under EU MDR. We translate IFUs for Class I through Class III devices into all 24 EU official languages, with ISO 17100 review process. eIFU (electronic IFU) localization also available for web-hosted device documentation.
Device labels, carton text, inner and outer packaging, and UDI labels. We work directly in InDesign, Illustrator, and your existing DTP files — no reformatting required. EU MDR Annex I General Safety and Performance Requirements (GSPR) for labeling addressed.
510(k) premarket notification documents, PMA applications, De Novo requests, and supporting technical documentation. Translated for FDA review. Our regulatory translators understand FDA formatting requirements and translate for reviewer comprehension, not just linguistic accuracy.
EU MDR 2017/745 Technical Documentation: clinical evaluation reports, post-market surveillance plans, PMCF plans, Declaration of Conformity, and GSPR checklists. Translated and formatted to meet Notified Body review standards for CE mark renewal under EU MDR.
Software as a Medical Device (SaMD) UI localization, embedded device software strings, and companion app translation. IEC 62304 software lifecycle documentation. We work in standard localization formats (XLIFF, PO, JSON) and integrate with your development pipeline.
Operator manuals, service manuals, field maintenance guides, and calibration procedures for complex medical equipment — imaging systems, surgical robots, diagnostic instruments. Technical accuracy reviewed by biomedical engineers on staff.
510(k), PMA, De Novo, EUA applications. 21 CFR Part 801 labeling requirements. FDA's guidance on translations in submissions. English source with Spanish, French, and other language requirements addressed.
EU MDR 2017/745 and EU IVDR 2017/746 compliance. All 24 EU official languages available. Technical File documentation, Declaration of Conformity, clinical evaluation. Notified Body review preparation.
Health Canada (bilingual EN/FR requirements), TGA Australia, ANVISA Brazil, PMDA Japan, NMPA China, MFDS Korea, COFEPRIS Mexico, and Gulf Cooperation Council markets. Market-specific formatting and regulatory terminology.
FDA requires that device labeling intended for US distribution be in English. However, if the device will be used by non-English-speaking patients or operators, the FDA recommends providing translated labeling. For devices sold in Puerto Rico or to Spanish-speaking populations, Spanish labeling is often required. For export 510(k)s, translations into the target market language are required.
EU MDR Article 10(11) requires that IFUs be made available in the official language(s) of the EU member states where the device is placed on the market. Practically, devices distributed across the EU need IFUs translated into all 24 EU official languages. Non-compliance with this requirement blocks market access and can result in Notified Body findings during conformity assessment.
An eIFU (electronic Instructions for Use) is an IFU hosted online rather than included as a printed insert. Under EU Regulation 207/2012, manufacturers of certain device categories can use eIFUs. eIFUs still require translation into all applicable EU languages — the electronic format does not reduce the language requirement. We localize eIFU web portals and hosted PDFs into all required languages.
A typical 20–30 page IFU translated into a single language: 3–5 business days. Full EU MDR package (IFU + labeling into all 24 EU languages): 2–4 weeks depending on document length. 510(k) submission translation: 1–2 weeks. Rush turnaround is available. We deliver all languages simultaneously — not sequentially — using parallel workflows.
We accept all standard formats: Microsoft Word, InDesign (IDML/INDD), PDF, HTML, XLIFF, XML, JSON, PO files, and Excel. For DTP files, we work in the original source files and return print-ready translated files in the same format. We do not require you to extract text — we handle all file engineering.
Device translation by regulatory specialists. FDA-compliant. EU MDR-ready. All major markets covered.