배경
A medtech firm expanding OEM business in EU/US needed English QMS mirroring Chinese controlled versions—design, purchasing, production, NC and CAPA procedures.
성과
Certification auditor confirmed English QMS matches Chinese controlled versions
서비스 내용:
지원 언어:
프로젝트 과제
Controlled versions
EN/CN version numbers and revision logs synced.
Procedure format
Unified Purpose/Scope/Responsibility structure.
Form fields
Record labels and instructions clear.
Audit deadline
Controlled release before certification audit.
접근 방법
품질, 컴플라이언스, 일정의 균형을 맞춘 단계별 납품.
Regulatory alignment
Confirm target markets, doc types and authority expectations.
Medical glossary
IFU/label/clinical glossary and do-not-translate lists.
Med TEP + DTP
Medical linguists, second review and layout fidelity.
Submission packaging
Organized deliverables per filing templates and change logs.
납품물
Project highlights
QMS structure
ISO 13485 document hierarchy fluency.
Version control
Synced EN/CN version numbers.
Forms
Field and instruction alignment.
Audit-ready
Pre-check against auditor focus areas.