Introduction
Localizing medical device documentation goes beyond translation: it requires adapting instructions, symbols and regulatory labeling to each market to ensure safety, compliance and usability. This guide provides a step-by-step checklist and technical validation practices to prepare documentation for distribution.
Preparation: roles and initial data
- Identify the target market and relevant regulatory authority (e.g., FDA, EMA, ANMAT).
- Assign responsibilities: technical owner, specialized translators, clinical reviewer and quality lead.
- Gather source materials: instructions for use (IFU), labels, technical datasheets, safety data sheets and packaging files.
Localization checklist (step by step)
1. Preparation & analysis
- Inventory all assets to localize (IFUs, labels, packaging, safety sheets, tutorials).
- Identify critical segments (warnings, contraindications, usage steps, safety parameters).
- Flag non-editable formats (images with embedded text, scanned PDFs) and plan extraction/layout.
2. Terminology & consistency
- Central glossary with device terms and measurement units.
- Translation memory to ensure consistency across documents and releases.
- Standard list of abbreviations and formatting conventions.
3. Symbols & pictograms
- Map symbols used on-device and in documentation to local accepted standards (IEC, ISO or local variants).
- Verify local mandatory symbol requirements and provide alternative text where needed.
- Create localized pictogram versions if required by regulation.
4. Labeling & packaging
- Check mandatory label elements (lot number, expiry date, manufacturer, regulatory marks).
- Confirm minimum font sizes and contrast for legibility per local rules.
- Ensure translations follow the order and formatting required by the local authority.
5. Instructions for use (IFU)
- Plain-language IFUs tailored to the end user (professional or patient).
- Technical review by clinical staff or biomedical engineering to avoid ambiguous steps.
- Comprehension testing with representative users (usability test).
6. Regulatory and legal requirements
- Include statements and warnings required by the local regulator.
- Check UDI/UDI-DI requirements and labeling formats.
- Verify conformity declarations and required markings (e.g., CE marking) for the target market.
7. Quality control & traceability
- Review workflow: translator → linguistic reviewer → technical expert → final approval.
- Change log and audit trail (who changed what and when).
- QA reports with a list of corrected issues.
8. Layout & final integration
- Layout checks: avoid truncating text in diagrams; preserve spacing and font sizes.
- Validate final PDFs and metadata (version numbers, dates).
- Print mock-up or packaging proof for verification.
9. Post-launch & maintenance
- Update plan for future versions and recalls.
- Feedback channel for users to report translation or comprehension issues.
- Maintain audit records and validation evidence.
Technical validation and usability testing
- Conduct a technical review by a clinician or biomedical engineer to confirm that instructions are interpreted correctly.
- Run usability tests with representative users to measure comprehension and execution times.
- Document findings and incorporate corrections into the glossary and translation memory.
Conclusion
Localizing medical device documentation requires a structured, multidisciplinary and traceable approach. This checklist helps reduce errors, improve user experience and lower regulatory risk. At SumaLatam we provide end-to-end localization and technical validation services for medical devices. Contact us to assess your documentation and design a localization plan tailored to your product.
