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.
Hintergrund
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.
Ergebnisse
Zero translation-related findings in NB first-round queries; supplements submitted on time
Leistungen:
Sprachen:
Projektherausforderungen
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.
Unser Vorgehen
Phasenweise Lieferung mit Balance aus Qualität, Compliance und Termin.
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.
Bereit für Ihr Übersetzungsprojekt?
Unser erfahrenes Team ist bereit, hochwertige Übersetzungsleistungen für Ihre Branche zu liefern.