MDR translation Tech file · CER · PMCF · DoC
Multilingual MDR technical files, CERs, PMCF and declarations of conformity—supporting NB and authorized rep communication.
MDR translation services
Documentation across the medtech lifecycle and compliance.
Regulatory dossiers
CTD/eCTD, technical files and DoC with multilingual translation and formatting.
IFU & labeling
IFUs, labels, package inserts and warnings with medical-grade translation and layout.
Clinical & CRO docs
ICF, CRF, CSR and ethics materials with medical TEP and consistency review.
QMS & audit files
SOPs, CAPA, internal audit reports and QMS documentation.
Product types
Devices, IVD and SaMD manufacturers.
Active devices
Monitoring, imaging and therapy devices
Non-active devices
Implants, surgical and consumables
IVD
IVD reagents and instruments
SaMD
Medical software and AI devices
CRO & sponsors
Clinical trials and regulatory outsourcing
Distributors
Import registration and change files
Herausforderungen Medizinprodukte-Übersetzung
Komplexe Zulassungspfade—Fehler riskieren Ablehnung oder Patientensicherheit.
Regulatorische Unterschiede
MDR/FDA/NMPA-Anforderungen variieren
Unser Ansatz:
Marktspezifische Vorlagen und Checklisten
Medizinische Terminologie
Klinische und technische Begriffe exakt
Unser Ansatz:
Medizin-Linguisten + zweite medizinische Prüfung
Kennzeichnung & Warnungen
IFU und Labels müssen Abbildungen entsprechen
Unser Ansatz:
Abbildungs-QC und DTP-Treue
Vertraulichkeit & Audit
Pre-Market-Daten sensibel
Unser Ansatz:
NDA, rollenbasierter Zugriff, Audit-Trails
Reference projects
Typical medtech delivery scenarios.
Class II EU MDR submission pack
IFU and technical file EN/DE/FR for notified body review.
Outcomes
Passed notified body written inquiries
Languages
FDA 510(k) IFU translation
CN IFU to FDA-format English IFU and labeling.
Outcomes
Faster response to FDA supplement requests
Languages
Warum Linguist für Medizintechnik
Medizinische und regulatorische Expertise gegen Ablehnung.
Medizin-Linguisten
Medtech-Übersetzer und Lektoren
Zulassungspfade
MDR/FDA/NMPA-Dossierstrukturen
IFU-Expertise
Strenge Warn- und Layout-Abstimmung
Sichere Compliance
Medtech-Datenstandards
Verwandte Ressourcen
Entdecken Sie passende Services, Branchenlösungen und Referenzprojekte.
Verwandte Services
Branchenlösungen
- Medical device translation
Medtech registration, IFU, labeling and clinical docs—medical linguists plus review for MDR/FDA/NMPA compliance.
- IFU translation
Medical device IFU translation with strict warning, illustration and layout alignment for FDA/MDR filings.
- FDA translation
FDA 510(k), PMA, Q-sub and labeling/IFU translation aligned with US FDA formats and terminology.