Anonymized case

Medical Devices · 3 months

EU MDR Technical File & CER Multilingual Program

Translated MDR technical files, clinical evaluation reports and PMCF plans for a Class IIb device with notified body review.

Result Zero translation-related findings in NB first-round queries; supplements submitted on time
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Mutual NDA available on request · Industry QA standards applied

Languages
3
Pages
2200+
Months
3
Translation NB findings
0

Background

Industry: Medical Devices Timeline: 3 months Languages: Chinese, English, German Services: MDR tech files, CER translation, PMCF docs, etc.

The client is in medtech and life sciences, where filings must align with FDA, EU MDR, NMPA and similar frameworks. “EU MDR Technical File & CER Multilingual Program” demands higher precision, traceability and confidentiality than typical business translation.

A client migrating CE certification to MDR needed upgraded MDD materials in EN/DE—GSPR mapping, risk management, clinical evaluation and post-market surveillance files.

Linguist assigned industry linguists, reviewers and a dedicated PM. Scope included MDR tech files, CER translation, PMCF docs, etc.. Within 3 months, we delivered and QA’d 3 languages—achieving: Zero translation-related findings in NB first-round queries; supplements submitted on time

Project challenges

  • MDR requirements

    Accurate GSPR and PMCF language.

  • Large CER

    Literature citations and data tables formatted consistently.

  • NB tone

    Language aligned with notified body expectations.

  • Cross-references

    Section numbering and reference chains intact.

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

  • Technical file
  • CER
  • PMCF plan
  • GSPR checklist

Project highlights

  • MDR migration

    MDD→MDR structure upgrade support.

  • CER expertise

    Clinical data and citation accuracy.

  • German NB

    German notified body phrasing.

  • Cross-refs

    Full reference chain QA.

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