Medical Device Documentation Translation
Full product documentation translation for an international medical device company, including technical specifications, user manuals, and safety guides.
Contexte
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.
Résultats
Delivered translated specs, manuals, and safety guides to support regulatory certification
Services :
Langues :
Défis du projet
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.
Notre approche
Livraison par phases équilibrant qualité, conformité et délais.
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.
Livrables
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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