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.
- ISO 17100 quality standards
- Professional review workflow
- Multilingual project management
Anonymized case - Languages
- 3
- Pages
- 2200+
- Months
- 3
- Translation NB findings
- 0
Background
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.
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.
Deliverables
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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