ComplyLingo for Regulatory Translation in Medical Devices
ComplyLingo helps regulatory and quality teams process IFUs, labels, manuals, and submission PDFs with structured extraction, terminology control, human review, and an audit-ready record of every change.
SUPPORTS SUBMISSIONS TO:
Medical Device Translation Is Broken
$0.25/word × 40 languages = Budget Nightmare
Traditional per-word translation costs spiral with every product update and market expansion. A single IFU revision can cost $15,000+ to propagate across all languages.
Where's the Audit Trail?
Regulators demand evidence that translations were reviewed, approved, and version-controlled. Email chains and shared folders don't cut it for ISO 13485 audits.
3 Weeks for a Label Translation?
Incumbent translation agencies take 2–4 weeks for medical device content. Your product launch shouldn't wait for a linguist's calendar.
From Upload to Submission-Ready in Hours, Not Weeks
Upload
Drop your PDF, scanned document, or image file. Our OCR engine extracts every text segment, preserving layout and structure. Supports IFUs, labels, manuals, regulatory submissions, and image-heavy files.
Translate
AI translates with regulatory terminology databases curated for PMDA, NMPA, MFDS, and ASEAN regulators. Translation memory ensures consistency across your entire document library.
Review
Assign internal reviewers or external linguists. Track changes, approve segment-by-segment, flag terminology questions. Every edit is timestamped and attributed.
Export with Audit Trail
Download translated documents in original format. Export a complete evidence package: translation certificate, reviewer sign-offs, terminology validation log, version history. Ready for regulatory submission.
Key Features
Intelligent Document Extraction
OCR for scanned PDFs, image-heavy files, and complex layouts. Extracts tables, headers, footnotes, and inline text while preserving document structure.
Regulatory Terminology Databases
Pre-built glossaries for PMDA (Japanese), NMPA (Chinese), MFDS (Korean), Thai FDA, and ASEAN regulators. Ensure every term matches authority expectations.
AI + Human Review Workflow
AI handles the first pass. Your team handles final approval. Multi-stage review with configurable roles: translator → medical linguist → SME → RA manager.
Submission-Ready Audit Trail
Every action logged with timestamp, user, and change delta. Export evidence packages formatted for ISO 13485 audits and regulatory submissions.
Translation Memory
Never translate the same sentence twice. Accumulated TM across your document library ensures consistency and reduces cost with every project.
API & QMS Integration
Push and pull documents from your QMS. Webhook notifications for review milestones. REST API for automation.
Cost reduction vs. traditional agencies
Languages supported
Not weeks — typical IFU turnaround
Audit trail coverage
How ComplyLingo Compares
| Feature | ComplyLingo | Translation Agency | Generic AI Tool |
|---|---|---|---|
| Self-serve access | ✅ | ❌ | ✅ |
| Medical device terminology | ✅ | ✅ | ❌ |
| Scanned PDF/image support | ✅ | ✅ | ❌ |
| Audit trail for submissions | ✅ | ❌ | ❌ |
| Human review workflow | ✅ | ✅ | ❌ |
| Cost for 5,000-word IFU (10 languages) | $2,000–$5,000 | $10,000–$25,000 | $50–$200 |
| Turnaround time | Same day | 2–4 weeks | Minutes |
Transparent Pricing. No Sales Calls Required.
All plans include a 14-day free trial. No credit card required.
Starter
Perfect for small teams
- ✓ 1 user
- ✓ 50 pages/month upload
- ✓ 25,000 words/month AI translation
- ✓ 2 language pairs
- ✓ Basic terminology management
- ✓ 90-day version history
- ✓ Audit log export
Professional
Best for growing teams
- ✓ 5 users
- ✓ 300 pages/month upload
- ✓ 150,000 words/month AI translation
- ✓ 5 language pairs
- ✓ PMDA, NMPA, MFDS terminology DBs
- ✓ Human review workflow
- ✓ Custom glossaries
- ✓ Full version history + change tracking
- ✓ API access
Enterprise
For large-scale operations
- ✓ 20 users
- ✓ Unlimited pages
- ✓ 500,000 words/month
- ✓ Unlimited language pairs
- ✓ All terminology DBs
- ✓ Multi-stage review workflow
- ✓ 21 CFR Part 11-ready signatures
- ✓ SSO / SAML
- ✓ Dedicated CSM
Get in Touch
Share your document mix, target markets, or current translation workflow. We respond within 1 business day.
Frequently Asked Questions
We support PDF, scanned PDF, JPEG/PNG (with OCR), DOCX, XLSX, XML, and HTML. We preserve original document structure and formatting in all cases.
Our AI uses domain-specific models trained on regulatory corpora plus curated terminology databases. For IFUs and labels, we achieve 92–95% accuracy on first pass. Human review is always recommended for regulatory submissions.
Yes. Our Japanese regulatory terminology database is curated from PMDA-published guidance documents and approved device labeling. We support STED format requirements.
Yes. Every translation action is logged with timestamp, user ID, and change delta. Evidence packages can be exported as PDF or CSV. Our Enterprise plan supports 21 CFR Part 11-compliant electronic signatures.
A typical IFU translation into 10 languages costs $10,000–$25,000 through a traditional agency with 2–4 week turnaround. With ComplyLingo Professional, the same job costs $2,000–$5,000 with same-day AI output plus human review.
Yes. We maintain curated terminology databases for all major regulatory bodies including NMPA, MFDS, PMDA, Thai FDA, HSA Singapore, and EU MDR.
Yes. You can invite external reviewers to your workspace. They get a reviewer-only view with tracked changes. No additional seat cost for reviewer-only access on Professional and Enterprise plans.
All data encrypted in transit (TLS 1.3) and at rest (AES-256). SOC 2 Type II certification in progress. GDPR-compliant. Served globally on Cloudflare's edge network. No training on your data — your translations are yours.
Ready to Cut Your Translation Costs by 60%?
Start your 14-day free trial. Upload your first IFU and see the results in minutes.
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