Translation for
regulated
industries.

In Germany, a certified translation (beglaubigte Ubersetzung) must be produced by a sworn translator (vereidigter Ubersetzer) who is officially authorised by a German court (Landgericht). The sworn translator attaches a signed statement to the translation confirming its accuracy and completeness. This certification is required for official submission to courts, authorities, and registration offices. We work with sworn translators for all language pairs in which certification is required.

From the first document, we build a project-specific bilingual glossary that maps your approved terminology to its target-language equivalents. This glossary is applied consistently by every translator working on the project and updated at the start of each new engagement. For long-term clients, the glossary grows with the relationship and covers product names, process terminology, regulatory terms and preferred phrasings. This is the only reliable way to achieve consistency across a body of content translated over time.

Our primary working languages are German, English, French, Italian, Spanish, Dutch, Polish and Czech. For regulated content, we restrict ourselves to language combinations where we have specialist translators with verifiable domain expertise. We do not use general-purpose translators and extend into new language pairs speculatively. If your required language pair is outside our standard range, we tell you directly rather than routing through intermediaries without the same level of quality control.

Yes. We translate EU MDR (2017/745) and EU IVDR (2017/746) technical documentation including Instructions for Use, clinical evaluation reports, risk management files and labelling content. For the EU AI Act, which applies from 2024 and 2025 in stages, we are translating conformity assessment documentation, technical documentation, and instructions for downstream providers and users. Our translators who work on these documents have experience in regulatory affairs and are familiar with EMA, MDR and AI Act terminology from existing guidance documents.

We accept DOCX, PDF (editable and scanned), PPTX, XLSX, XML, HTML, XLIFF, SRT and most standard formats. For scanned PDFs, OCR processing is included. For InDesign and specialist publishing formats, please contact us in advance. We deliver in the same format as the source document unless you specify otherwise, and always maintain original formatting and layout.

Yes, as standard. Our translators work under confidentiality agreements with us, and we are prepared to sign client-specific NDAs before project commencement. For patent translation, medical device documentation and legal agreements, this is a routine part of the engagement process. Please send your NDA requirements at the time of your initial inquiry and we will review and sign before any materials are shared.

Machine translation post-editing (MTPE) involves taking output from a trained MT engine and having it reviewed and corrected by a specialist human translator. The result is a translation that has been touched and validated by a qualified human linguist, but at a lower cost than full human translation from scratch. MTPE is appropriate for high-volume, lower-stakes content where speed and cost efficiency matter more than maximum linguistic quality. It is generally not appropriate for legal agreements, sworn translations, medical Instructions for Use, or clinical documentation where accuracy is directly linked to legal or patient safety consequences.

Send us your document with a brief describing target language, intended use, regulatory context and deadline. We review it and respond with a fixed price quote within 4 hours. We do not give word-count estimates from file metadata without reading the content. The quote reflects actual complexity, not just character count. Once you accept the quote and payment is confirmed, work begins.