Introduction
Localizing documentation for medical devices requires technical accuracy, traceability and regulatory compliance. Translation alone is not enough. Instructions for use and labels must be adapted to local regulations, symbols, units and user practices. The checklist below provides a validated, step-by-step approach to ensure correct localization.
Key principles before starting
- Define scope: which assets need localization, such as IFUs, labels, technical data sheets and packaging materials.
- Identify target jurisdictions and applicable regulations.
- Assign roles: project manager, specialized translators, clinical reviewers and quality owner.
Essential regulatory and technical requirements
- Approved terminology: maintain a glossary validated by clinical experts per target language.
- Units and formats: adapt measurement units, date formats and numeric notation to local conventions.
- Symbols and pictograms: ensure icons meet local standards and are culturally appropriate.
- Mandatory statements: include regulatory warnings, contraindications and required liability text as specified by authorities.
- Font size and readability: apply minimum sizes and contrast to guarantee legibility in real use.
- Version control: record versions, dates and approvals for each language.
Recommended workflow (steps)
- Source analysis: review structure, tables, serial references and cross-links.
- Resource preparation: export glossaries, translation memories and editable source files.
- Specialized translation: translators with device experience perform initial localization.
- Linguistic review: stylistic and clarity checks in the target language.
- Clinical review: healthcare professional validates medical accuracy and safety-critical instructions.
- Formatting QA: verify layout, alignment, numbered steps, tables and reference consistency.
- Label verification: check codes, symbols and compliance with labeling rules.
- User testing: comprehension tests with representative users and clinicians.
- Sign-off: technical and legal approvals are recorded prior to release.
- Publication and archiving: final package with metadata, version stamp and backup.
IFU-specific checklist items
- Are warnings highlighted and translated with equivalent emphasis?
- Do step-by-step instructions preserve logical order and use clear, direct verbs?
- Are precautions on contraindications and waste handling adapted?
- Have units, dosages and conversions been checked?
- Are diagrams and figures relabeled consistently with the text?
- Has readability been tested in print and on screen?
- Are local regulatory references included when required?
Labeling checklist items
- Required information present: product name, lot number, expiry date and storage instructions.
- Manufacturer and local representative details where required.
- Standardized symbols and legends if mandated.
- Traceability: barcodes, serial numbers and other identifiers.
- Pictogram review for cultural sensitivity.
- Minimum font size and contrast checks for real product use.
Testing and final quality control
- Run automated checks for terminology consistency across assets.
- Perform read-aloud reviews to catch ambiguous procedural steps.
- Conduct observational user tests with clinical staff or end users.
- Produce a nonconformance report and corrective action plan before release.
Traceability and audit documentation
- Keep a version history with date, author, clinical approver and rationale for changes.
- Store evidence of clinical and legal approvals.
- Include QA logs and user test results.
- Archive final package in a secure repository with controlled access.
Conclusion and next steps
Thorough localization safeguards patient safety and reduces regulatory risk. Following this technical checklist helps ensure that IFUs and labels comply with local rules and are user friendly for clinicians and patients. Contact us to tailor the localization workflow and validation plan for your device and target markets.
