배경
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.
성과
Delivered translated specs, manuals, and safety guides to support regulatory certification
서비스 내용:
지원 언어:
프로젝트 과제
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.
접근 방법
품질, 컴플라이언스, 일정의 균형을 맞춘 단계별 납품.
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.
납품물
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.