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Translation for Device Manufacturers

Device documentation, where consistency is a regulatory expectation.

Instructions for use, labelling, clinical evaluation and technical files — translated with controlled terminology across every market, prescribed wording respected, and layouts that survive the target language.

What makes it different

The same sentence, identically, in eleven places

A single device produces a remarkable amount of text: an instructions-for-use document, a quick-reference card, labelling, packaging, training material, service documentation, often an app interface. A warning that appears in six of them must read identically in all six, in every market.

That is a terminology management problem before it is a translation one, and it is where most device localization quietly goes wrong. Different translators, different months, different files — and the warning on the label no longer matches the warning in the manual. A notified body will notice.

The second constraint is that some wording is not yours to improve. Symbol descriptions, certain warnings and regulatory statements are prescribed by the standard or the market. A translator producing more elegant phrasing has produced a compliance problem.

How we work

What device manufacturers get from us

  1. 1

    A device glossary before translation begins

    Component names, warnings and recurring phrasing fixed once, then enforced across every deliverable and every revision.

  2. 2

    Prescribed wording used verbatim

    Mark what is mandated and it is reproduced exactly, not rewritten to read better.

  3. 3

    Clinically experienced linguists

    Assigned by familiarity with regulatory and clinical texts rather than general technical translation.

  4. 4

    Structure preserved

    XML, DITA and structured authoring formats return with markup intact rather than flattened into prose.

  5. 5

    Layout adjusted per language

    Text that expands a third in German cannot sit in a box built for English. DTP is part of the work.

  6. 6

    Revisions cost what changed

    Translation memory means an IFU update touches new content only, and the rest stays identical to what is in market.

What we translate

Device documentation we handle

Instructions for use

Full IFUs, quick-reference guides and patient-facing versions.

Labelling and packaging

Where wording and symbols are frequently market-specific.

Clinical evaluation reports

Literature reviews and post-market surveillance documentation.

Technical files

Material forming part of a conformity assessment submission.

Service and maintenance manuals

For field engineers and authorised service partners.

Training material

For clinicians, distributors and internal teams.

Software and app interfaces

Companion applications and embedded device interfaces.

Regulatory correspondence

Submissions, queries and responses to notified bodies.

Timing

How long it takes

Type of projectTypical delivery
Short documents and updates
IFU revisions, single labels, brief guides
2–3 business days
Full documentation sets
Manual, labelling, training and quick-reference together
Depends on volume and complexity
Multi-market programmes
Several languages, DTP, ongoing revision cycles
Scoped before quoting

Larger or more complex projects may require additional review time. Quotation requests are usually reviewed within 30–60 minutes during business hours, Monday to Friday, 8:00 AM to 6:00 PM Central Time.

Questions

Medical Devices, answered

We work across 230+ language combinations, which covers every EU official language plus the major Asian, Middle Eastern and Latin American markets. Tell us which markets you are entering and we will confirm coverage before you commit to a timeline — including whether any require a specific approach to terminology.

Yes, and it shapes how we handle the work. Warning phrasing, symbol descriptions and certain regulatory statements are defined by the standard or the receiving market. Improving them is not an improvement. Mark anything prescribed when you send it and it will be used exactly as specified.

A device generates a manual, a quick-reference guide, labelling, packaging, training material and often an app interface — and the same warning must read identically in all of them. A device-specific glossary is built at the outset and enforced by translation memory across every deliverable and every subsequent revision.

InDesign, FrameMaker, XML, DITA and structured content from most authoring systems, alongside Word and PDF. Send source files rather than PDFs where you can — a structured source returns as a usable file, whereas a PDF has to be rebuilt, which costs time and introduces error.

German runs roughly a third longer than English and Finnish longer still, while Chinese contracts. A layout built around English will break in at least one target market. Desktop publishing is part of the work: you receive files that are usable, not files somebody has to rebuild.

Translation memory means a revision touches only what changed. When an IFU is updated, the unchanged sections stay identical to what is already in market — which matters for regulatory consistency as much as for cost.

Yes — clinical evaluation reports, literature reviews, post-market surveillance documentation and material forming part of a technical file. This work is assigned to linguists experienced in clinical and regulatory texts rather than general technical translators.

It depends on volume, format complexity and how much DTP is involved. A short IFU update is quick; a full documentation set across twelve languages is scoped before quoting so the date reflects the actual work rather than an optimistic estimate.

Discuss your documentation

Tell us the device, the markets and the formats you author in. A Project Coordinator will scope the programme properly before quoting.

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