Healthcare · 2 months
Medical Device Documentation Translation
Full product documentation translation for an international medical device company, including technical specifications, user manuals, and safety guides.
- PSB Reg. No. 3101150909750
- TAC Institutional Member
- ISO 17100 Certified Quality
- Strict Enterprise NDA
Anonymized case - Languages
- 4
- Months
- 2
- Files
- 120+
- Review coverage
- Full
Background
The client is in medtech and life sciences, where filings must align with FDA, EU MDR, NMPA and similar frameworks. “Medical Device Documentation Translation” demands higher precision, traceability and confidentiality than typical business translation.
An international medtech client needed specifications, IFUs, safety guides and registration dossiers translated for EU and Asia-Pacific filings. Medical accuracy, layout fidelity and version traceability were mandatory.
Linguist assigned industry linguists, reviewers and a dedicated PM. Scope included Technical Documentation, Certified Translation, Quality Review, etc.. Within 2 months, we delivered and QA’d 4 languages—achieving: Delivered translated specs, manuals, and safety guides to support regulatory certification
Project challenges
Clinical precision
A single term error can affect review or patient safety.
Regional filing rules
IFU structure and warnings differ by authority.
Complex layouts
Diagrams, tables and warning icons must align with source.
Confidentiality
Pre-market product data under strict access control.
Our approach
Phased delivery balancing quality, compliance and timeline.
Medical glossary
Built from client legacy assets and public standards.
Med linguists
Medical translators plus second medical reviewer.
DTP fidelity
Restored layouts with consistent figure numbering.
Submission pack
Organized deliverables for regulatory submission.
Deliverables
Project highlights
Medical team
Medtech-experienced linguists led the work.
Filing-ready
Deliverable structure aligned with common paths.
Visual accuracy
Warnings and illustrations strictly mapped.
Secure workflow
NDA, role-based access and redaction.
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