Industry illustration

Medical Devices · 2 months

ISO 13485 QMS Documentation Translation

Translated quality manual, procedures, work instructions and forms for EN ISO 13485 certification audit.

Result Certification auditor confirmed English QMS matches Chinese controlled versions
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Mutual NDA available on request · Industry QA standards applied

Languages
2
Procedures
86
Months
2
Audit pass
1

Background

Industry: Medical Devices Timeline: 2 months Languages: Chinese, English Services: Quality manual, Procedures, SOP translation, etc.

The client is in medtech and life sciences, where filings must align with FDA, EU MDR, NMPA and similar frameworks. “ISO 13485 QMS Documentation Translation” demands higher precision, traceability and confidentiality than typical business translation.

A medtech firm expanding OEM business in EU/US needed English QMS mirroring Chinese controlled versions—design, purchasing, production, NC and CAPA procedures.

Linguist assigned industry linguists, reviewers and a dedicated PM. Scope included Quality manual, Procedures, SOP translation, etc.. Within 2 months, we delivered and QA’d 2 languages—achieving: Certification auditor confirmed English QMS matches Chinese controlled versions

Project challenges

  • 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.

Our approach

Phased delivery balancing quality, compliance and timeline.

  1. 01

    Regulatory alignment

    Confirm target markets, doc types and authority expectations.

  2. 02

    Medical glossary

    IFU/label/clinical glossary and do-not-translate lists.

  3. 03

    Med TEP + DTP

    Medical linguists, second review and layout fidelity.

  4. 04

    Submission packaging

    Organized deliverables per filing templates and change logs.

Deliverables

  • Quality manual
  • Procedure pack
  • Work instructions
  • Localized forms

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.

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