背景
A medtech firm expanding OEM business in EU/US needed English QMS mirroring Chinese controlled versions—design, purchasing, production, NC and CAPA procedures.
成果
Certification auditor confirmed English QMS matches Chinese controlled versions
サービス内容：
対応言語：
プロジェクトの課題
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.
アプローチ
品質、コンプライアンス、納期のバランスを取った段階的納品。
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.
成果物
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.