Medical Device Translation
Expert translation for EU MDR/IVDR compliance and global market access.
Global Market Access for Medical Devices
Medical device manufacturers face complex regulatory requirements. The EU MDR and IVDR mandate documentation in the official languages of each member state.
Our specialized translators understand technical requirements, regulatory terminology, and formatting standards.
Medical Device Documents We Translate
Comprehensive translation for all device documentation.
User Documentation
- Instructions for Use (IFUs)
- User Manuals
- Quick Start Guides
- Service Manuals
- Training Materials
Device Labeling
- Primary Device Labels
- Secondary Packaging
- UDI Labels
- Warning Labels
- Sterility Labels
Technical Documentation
- Clinical Evaluation Reports
- Risk Management Files
- Technical Specifications
- Post-Market Surveillance
- SSCP Summaries
Regulatory Compliance
Translations meet requirements of major medical device regulations.
EU MDR (2017/745)
Medical Device Regulation for EU member states.
- All 24 EU official languages
- Annex I General Safety requirements
- UDI-DI labeling compliance
EU IVDR (2017/746)
In Vitro Diagnostic Regulation.
- IVD-specific terminology
- Performance evaluation reports
- Class A-D documentation
FDA Requirements
US FDA device submissions.
- 510(k) submissions
- PMA documentation
- QSR compliance
Other Markets
Global regulatory requirements.
- Japan PMDA / MHLW
- China NMPA
- Health Canada / MDSAP
Frequently Asked Questions
Which EU languages are required for device labeling?
EU MDR requires documentation in the official languages of each member state where the device is marketed.
Do you translate clinical evaluation reports?
Yes, we translate CERs and other technical documentation for EU MDR compliance.
Can you handle IFU updates?
Yes, we maintain translation memories for consistency between versions.
What is your turnaround for IFU translation?
5-7 business days standard, expedited services available.
Request a Medical Device Translation Quote
Get a customized quote within 24 hours.
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Response within 24 hours - EU MDR/IVDR compliant - ISO 17100