Medical devices

Device documentation.Kept in agreement.

IFU, label and software translation with connected terminology, review and version control.

Illustrative respiratory device beside an instruction booklet and label layouts
AI-generated illustration. Not actual client or project imagery.

One product. Connected documentation.

A mode name, warning or instruction may appear in several places. We help coordinate the localization of those materials, with clear references and review responsibilities.

For medical device manufacturers, documentation teams and regulatory affairs reviewers.

Instructions for use

Localize IFUs against approved source versions, reference resources and review requirements.

Labels & packaging

Work within label space, symbol and layout constraints, with language consistent across the document set.

Software text

Keep interface terminology connected to operating instructions, modes and alarm information.

Quick-start guidance

Coordinate supporting guides with the related IFU and product language resources.

What your team receives

  • Localized document packages
  • Agreed layout files and PDFs
  • Terminology resources
  • QA and version records

Review built into the work.

Agree the checks and responsibilities before production begins.

  1. Agree responsibilities

    Define languages, source versions, critical terminology and the client reviewers who approve safety content.

  2. Coordinate language and layout

    Review meaning and terminology, then check fonts, symbols, overflow, cross-references and final presentation.

  3. Track the changes

    Identify affected materials when source content changes. Connect revised files with their terminology and version records.

Your designated reviewers retain approval of critical safety content, product claims and regulatory requirements. Localization does not guarantee regulatory clearance.

Illustrative respiratory device beside an instruction booklet and label layouts
AI-generated illustration. Not actual client or project imagery.

A relevant project

Device documentation in 13 languages

A home respiratory device project brought instructions, labels and software text into one coordinated multilingual workflow.

13
Target languages
68 pages
Source IFU
Read the case study

Before we start.

Share document types, target languages and markets, source formats, version status and review schedule.

Does this service guarantee regulatory approval?

No. Our scope is the agreed language and formatting work. Regulatory decisions remain with the relevant authorities and review bodies.

Is layout included?

Layout and DTP can be included in the project scope. Share source files and final format requirements so the work can be assessed.

Who approves safety terminology?

Your designated reviewers approve critical safety terminology and product statements. Their decisions should be reflected in the language resources and document versions.

What happens when the source changes?

A change review identifies the affected IFU, labels, software and guides. The revised scope and review steps are agreed before the updated handoff.

Useful before you start.

Explore related planning questions from our existing Blog.

Tell us what you need to deliver.

Share document types, target languages and markets, source formats, version status and review schedule.

Request a Quote