Regulated content

Life sciences translation
where the language is set by law

For devices, medicines and trials sold or run in the EU, the language of the paperwork is not a choice — each member state decides what its patients and users must be able to read. We translate the documents that obligation lands on.

  • Instructions for use and labelling
  • Package leaflets and product information
  • Clinical trial documents and lay summaries
  • Patient questionnaires and consent forms
  • Consistent terminology across the whole set
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    The obligation, briefly

    The EU Medical Device Regulation requires the information supplied with a device — the instructions for use above all — to be in an official language determined by each member state where the device reaches its user or patient. The in-vitro diagnostics regulation carries the same obligation. For medicines, the labelling and package leaflet must be in the official language of every state where the product is placed on the market.

    Clinical trials add one more: a summary of results written for laypeople, expected in the local language of each country where the trial ran.

    The member states do not agree with each other. Some accept English for professional-use devices; others require the national language regardless. Which rule applies depends on the product, the user and the market — tell us all three and we will scope the language set with you.

    Documents we translate

    The document types the language rules most often land on.

    How we work on regulated texts

    • Native specialists

      Translators working exclusively into their own language, chosen for experience with medical and technical texts.

    • A second pair of eyes, always

      Every translation is revised in full by a second linguist. For this content that is not a premium option — it is the process.

    • One termbase across the set

      A device name, a contraindication, a warning — rendered identically in the leaflet, the label and the IFU, in every language, every revision.

    • All target markets at once

      One coordinated delivery across your language set, rather than a different vendor and a different glossary per country.

    A word on scope

    Life sciences translation attracts big claims, so here is our honest one. We are a small agency. We do not run validated back-translation panels, and we will not pretend to be a two-hundred-linguist regulatory machine with a badge for everything.

    What we do is translate regulated documents carefully, revise every line with a second linguist, keep your terminology consistent across the whole document set, and tell you plainly when a job needs something we do not provide. If your project needs a full linguistic validation programme, we will say so on day one — not after you have committed.

    Happy to be of service,

    Founder

    Frequently asked questions

    Tap any question to see the answer!
    Which languages does my device documentation need?
    It depends on the markets and on the device. Each EU member state determines the language for the information supplied with devices sold there, and their choices differ — some accept English for professional-use devices, many require the national language. Tell us the markets and we will confirm the set with you before quoting.
    Do you translate instructions for use?
    Yes — IFUs, labels and package leaflets are precisely the documents the language rules apply to. We keep the terminology identical across all three, which is what a reviewer checks first.
    Can you keep our terminology consistent across updates?
    Yes. We maintain a termbase and a translation memory for your products, so revision two uses the wording of revision one, and only what changed is retranslated and charged.
    Do you use machine translation on regulated content?
    Not as a starting point for labelling, leaflets or anything a patient reads. Where a machine draft genuinely helps — internal documentation, high-volume technical annexes — we say so openly, and a qualified human revises every line.
    Do you provide certified translations for submissions?
    Yes, where the receiving authority requires one. Tell us which authority, and we will deliver the certification in the form it accepts.
    What do you not do?
    Full linguistic validation with patient cognitive debriefing, and regulatory consulting on classification or market access. If your project needs those, we will tell you at the quote stage and stick to the part that is ours.