Instructions for use
IFUs, quick-reference guides, setup procedures, operating instructions, precautions and warnings.
Language solutions for regulated MedTech
Precision in every language. Confidence in every detail.
Specialist translation and localisation for medical device manufacturers, diagnostic technology providers and regulated healthcare equipment businesses.
From instructions for use and product labels to equipment software, technical manuals and training videos, we help keep multilingual content accurate, consistent and ready for your controlled review process.
Project-specific workflows · Confidential handling · Optional additional quality review
Medical device documentationEquipment software & UIRegulated-market language needsMultilingual QA & DTP
The critical distinction / 01
When the wording matters as much as the technology.
Medical device content sits at the intersection of clinical meaning, engineering precision and regulated market requirements. A unit, warning, indication, control label or procedural instruction must be understood as intended by its user.
PangeaVox coordinates specialised linguists, terminology management, technical localisation and agreed review stages to support manufacturers and their quality and regulatory teams.
Explore our quality assurance approachSpecialist content / 02
One product. Multiple content types. One consistent vocabulary.
We support both the documents supplied with equipment and the digital content clinicians, technicians and other intended users interact with.
Labelling & packaging
Product labels, packaging text, safety notices, symbols and accompanying explanations.
Device software & UI
Menus, messages, alerts, parameters, control labels, contextual help and related software strings.
Technical documentation
Specifications, installation guidance, servicing and maintenance manuals, technical descriptions and related files.
Quality & regulatory materials
Controlled procedures, validation-related records and regulatory-supporting content, within an agreed scope.
Instructional video & media
On-screen text, training scripts, subtitles and human-checked AI-assisted dubbing where suitable.
Controlled delivery / 03
Quality controls matched to the risk and purpose of the content.
Rather than treating all files as ordinary marketing copy, we scope the required expertise, checks and delivery evidence before work begins.
How we manage translation projects01
Specialist terminology
Approved product names, intended-use language, clinical and engineering terms, and consistent abbreviations across files and interfaces.
02
Safety-critical wording
Explicit attention to warnings, contraindications, instructions, measurements, units and numbers without unauthorised changes to source meaning.
03
Document & version discipline
Clear file identification, controlled updates, technical placeholders and traceable feedback according to the agreed project specification.
04
Additional QA on request
Independent review, focused checks or in-context linguistic UI verification can be added to the agreed scope when enhanced assurance is needed.
05
Layout & multimedia checks
Multilingual desktop publishing, expansion-aware layouts, subtitle timing and human review of AI-assisted audio as applicable.
Regulatory context / 04
Language requirements are market-specific. Your review process should be too.
EU medical device and in vitro diagnostic regulations set requirements for information accompanying devices. Member State language requirements can differ, including for instructions, labelling and graphical user interfaces. Outside the EU, applicable requirements depend on the target market and product.
We support the linguistic and localisation workstreams; the manufacturer and its regulatory specialists retain responsibility for confirming requirements, approving technical content and determining product compliance.
PROJECT ALIGNMENT
- 01 Target countries, not just target languages
- 02 Intended user and device context
- 03 Approved product terminology and source revision
- 04 Required reviewer and sign-off stages
- 05 Agreed file formats and release handover
Translation is not a substitute for regulatory assessment or product certification.
Selected client project / 05
Confidential client · Major international company
Equipment documentation, software UI and training media. Seven languages, one coordinated project.
For a major international company, PangeaVox translated a complete set of equipment documentation and the accompanying user interface into three European and four Asian languages, working to a compressed schedule.
At the client's request, we incorporated an additional quality control stage. The project also included multilingual desktop publishing (DTP) and AI-assisted dubbing of training videos, with human checking of the dubbed content.
Documentation & UI translationAdditional client-requested QAMultilingual DTPHuman-checked AI dubbing
The client's name, device identity and language combinations are withheld to respect confidentiality.
Project workflow / 06
From controlled source files to market-ready language assets.
Scope, review and handover are agreed for each product, language group and technical format.
- 01
Assess
Review source files, markets, languages, device context, risks and deadlines.
- 02
Prepare
Confirm terminology, source versions, file handling and approval roles.
- 03
Localise
Translate documentation, UI strings, layouts and agreed media assets.
- 04
Verify
Carry out the agreed linguistic QA and optional independent or in-context checks.
- 05
Deliver
Provide the agreed multilingual files, findings and handover information.
Start with the right brief / 07
What we need to quote your project.
Share the intended markets, product context, source files and review expectations. Our team will recommend an appropriate delivery workflow.
- Target languages and intended countries
- Device type, intended users and content purpose
- Approved source documentation and revision history
- Editable UI exports, screenshots and technical constraints
- Label, layout and multimedia requirements
- QA, reviewer sign-off and delivery deadlines
If source material contains confidential design information or sensitive data, contact us first to agree a suitable transfer method.
Discuss secure project handoverFrequently asked / 08
Questions from MedTech teams.
Requirements are reviewed against the intended device, markets and the scope of your language project.
Do you translate instructions for use and medical device labelling?
Yes. We support IFUs, packaging and labelling content, safety information, technical documentation and associated device software. The applicable language and approval requirements must be confirmed for each target market.
Can you localise equipment software interfaces?
Yes. We can work with UI strings, alerts, parameters, placeholders and available interface context. In-context linguistic review or testing can be scoped separately where a suitable environment is provided.
Can we request an additional quality assurance stage?
Yes. Additional independent linguistic review, targeted verification and documented feedback can be scoped to match your quality requirements. The project brief should identify any required reviewer roles or acceptance criteria.
Do you offer desktop publishing and training video dubbing?
Yes. Multilingual DTP, subtitle localisation and AI-assisted dubbing with human checking may be incorporated into the same project, subject to source materials, target languages and agreed delivery specifications.
Does a translation confirm MDR, IVDR or FDA compliance?
No. Translation and linguistic QA support the manufacturer's compliance process but do not independently certify a device, its documentation or its regulatory status. Regulatory approval and final product decisions remain with the responsible manufacturer and specialists.
Can you accommodate urgent multilingual launches?
We can assess accelerated schedules and coordinated language deliveries. Feasibility, reviewer availability and any urgency pricing are confirmed after examining the source material and quality requirements.
Language expertise for MedTech
Your device has a purpose.
Every language should communicate it clearly.
Talk to PangeaVox about documentation, interface localisation, QA, DTP and training media for your next international project.