End-to-End Regulatory Translation for Every Document Type
From scanned IFUs to complex STED packages, ComplyLingo handles the full spectrum of medical device regulatory documentation.
Document Types We Handle
Instructions for Use (IFUs)
Multi-language IFU translation with layout preservation. Supports complex formatting, tables, diagrams with embedded text, and symbol legends.
Device Labels & Packaging
Label text extraction and translation with UDI-compliant formatting. Supports multi-panel labels, fold-out booklets, and blister pack text.
Regulatory Submissions
STED packages, 510(k) summaries, CE technical files, NMPA registration dossiers. Structured translation with terminology validation.
Clinical Evaluation Reports
CERs, PMCF reports, and literature reviews. Scientific terminology management with consistent usage across documents.
Software UI & eLabeling
Localization of device software interfaces, eIFUs, and digital labeling platforms. Export in XLIFF, JSON, or XML.
Training Materials & SOPs
Internal training documents, surgical technique guides, and standard operating procedures for global teams.
Post-Market Surveillance
Adverse event reports, field safety notices, periodic safety update reports, and vigilance documentation.
Marketing & Commercial
Brochures, website content, trade show materials, and HCP communications with compliance assurance.
Our Translation Workflow
Intelligent Ingestion
- ▸ Upload any file format (PDF, scanned, image, DOCX, XLSX, XML)
- ▸ AI-powered OCR extracts text from scanned documents and images
- ▸ Layout analysis preserves document structure
- ▸ Text segmentation identifies translatable units while protecting non-translatable elements
AI Translation with Regulatory Intelligence
- ▸ Neural machine translation with medical device domain adaptation
- ▸ Automatic terminology lookup against regulatory authority databases
- ▸ Translation memory matching — leverage historical translations
- ▸ Confidence scoring — segments below threshold auto-flagged for review
- ▸ Glossary enforcement — restricted terms locked to approved translations
Collaborative Human Review
- ▸ Web-based review interface — no software installation required
- ▸ Side-by-side source/target view with inline editing
- ▸ Tracked changes with attribution
- ▸ Comment threads on individual segments
- ▸ Multi-stage approval workflow (configurable per project)
- ▸ External reviewer access without additional seat cost
Export & Evidence
- ▸ Download translated documents in original format with formatting preserved
- ▸ Translation certificate with project metadata
- ▸ Segment-level audit trail
- ▸ Terminology validation report
- ▸ Version comparison (diff) against previous translations
- ▸ Evidence package formatted for ISO 13485 audit documentation
Supported Regulatory Frameworks
🇺🇸 FDA (USA)
510(k), PMA, De Novo
🇪🇺 EU MDR / IVDR
CE marking, STED, SSCP
🇯🇵 PMDA (Japan)
Shonin, QMS
🇨🇳 NMPA (China)
Registration, classification
🇰🇷 MFDS (South Korea)
KGMP
🇸🇬 HSA (Singapore)
Reference approval
🇹🇭 Thai FDA
Medical device registration
🇦🇺 TGA (Australia)
ARTG listing
🇮🇳 CDSCO (India)
Registration
🏘️ ASEAN AMDD
Harmonized framework
Why Medical Device Teams Choose ComplyLingo
Cost Reduction
AI + translation memory + regulatory terminology databases reduce per-word costs by 60–70%. No more paying $0.25/word for every revision across all languages. A typical IFU that costs $15,000 with a traditional agency costs $5,000 with ComplyLingo.
Speed
Parallel AI processing reduces turnaround from weeks to hours. Upload an IFU in the morning, have AI translation by afternoon, human review by next day. Perfect for urgent regulatory submissions and product launches.
Compliance Confidence
Audit trail, terminology validation, and evidence packages eliminate regulatory risk. Every action timestamped and attributed. Export PDF evidence for ISO 13485 audits. Your translations are submission-ready from day one.
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