Medical translations for medical device manufacturers

Yes, that's our main focus in this specialization: IFUs, technical documentation, labels, and device software, translated into the languages of the markets where you register your device.

Not for regulated content: only humans work there, in a process involving three pairs of eyes. AI assists with low-risk materials, always under human supervision. We always inform you of the level we propose and the reasons behind it.

Yes, an NDA before the first file is our standard practice, not an exception.

No, we work for companies: manufacturers, importers, and distributors of devices, as well as healthcare entities.

Into the languages of the markets where you register the device. The MDR requires that the instructions be in a language the user understands in every country where the device is marketed, and that's what we're working toward. Polish and Czech are our native languages. We handle English and German on a daily basis, and the remaining European languages are handled by verified medical specialists with whom we have been working for years. One process and one error assessment scale for everyone.

A specialist translator handles them — someone for whom medical terminology, risk classes, and the language of the standard are everyday matters, not exoticities. For less common languages, we select verified medical specialists with whom we have been working for years. Another person independently reviews the entire document, because a single imprecise phrase in the device documentation can alter its intended use.

Yes, in addition to instructions for use and technical documentation, we translate labels and markings, interfaces for medical software and devices with screens, training materials, as well as quality documentation and procedures. We deliver the format 1:1, working with InDesign files, XML, exports from documentation systems, and PDFs for reproduction.

Because there are no small errors in the documentation of a medical device. Regulated content is handled exclusively by humans, with three pairs of eyes involved: a specialist translator, an independent reviewer, and an internal, tool-based QA process for numbers, tags, and terminology. This is the Premium level, starting at €0.12 per word. Low-risk materials can be translated more affordably using AI-assisted versions, but we always inform you of the recommended service level and the reasons behind our choice.

Through a process designed to ensure that a critical error—one that distorts meaning or alters usage—simply cannot slip through. We store terminology in a glossary and translation memory, numbers and symbols undergo automated QA, and an independent editor reviews the entire text. We are responsible for the quality and linguistic integrity of the translation. The formal conformity assessment of the product remains your responsibility, but you receive text that does not hinder it.

Yes, and that's one of the more common issues we detect. The product's marketing texts must align with what you declare in the documentation, so we maintain a shared glossary for the IFU, labels, software, and promotional materials. This ensures that the product is described consistently in every language and in every type of communication, and you don't risk any discrepancies between the instructions and the advertising.