Industry illustration

Medical Devices · 2.5 months

Medtech Clinical Evaluation & Trial Documentation

Translated clinical evaluation reports, protocols, informed consent and CRF guides for parallel CE and NMPA pathways.

Result Ethics committee and CRO confirmed English trial docs ready for multicenter studies
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Mutual NDA available on request · Industry QA standards applied

Languages
2
Words
650k
Months
2.5
Ethics approvals
3

Background

Industry: Medical Devices Timeline: 2.5 months Languages: Chinese, English Services: Clinical evaluation, Trial protocols, Ethics documents, etc.

The client is in medtech and life sciences, where filings must align with FDA, EU MDR, NMPA and similar frameworks. “Medtech Clinical Evaluation & Trial Documentation” demands higher precision, traceability and confidentiality than typical business translation.

A novel device pursued parallel CE and NMPA registration—clinical evaluation and trial materials needed in bilingual form for CROs, ethics committees and authorities.

Linguist assigned industry linguists, reviewers and a dedicated PM. Scope included Clinical evaluation, Trial protocols, Ethics documents, etc.. Within 2.5 months, we delivered and QA’d 2 languages—achieving: Ethics committee and CRO confirmed English trial docs ready for multicenter studies

Project challenges

  • Clinical terminology

    Endpoints and AE classification per standard usage.

  • Ethics tone

    ICF language per ethics review conventions.

  • Dual pathways

    Different EU MDR vs. NMPA clinical language.

  • Complex tables

    Statistics tables and footnotes preserved.

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

  • CER sections
  • Trial protocols
  • Informed consent
  • CRF completion guides

Project highlights

  • Clinical fluency

    GCP and literature context.

  • Data accuracy

    Tables and stats terms precise.

  • Ethics tone

    Professional ICF language.

  • Dual pathway

    Parallel CE/NMPA support.

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