Medical Device Translation
Expert translation for EU MDR/IVDR compliance and global market access. IFUs, labeling, and technical documentation across 150+ languages.
Global Market Access for Medical Devices
Medical device manufacturers face increasingly complex regulatory requirements for product documentation. The EU MDR (2017/745) and EU IVDR (2017/746) mandate that device documentation be provided in the official language(s) of each member state where the device is placed on the market.
Our specialized medical device translators understand the technical requirements, regulatory terminology, and formatting standards required for compliant device documentation across global markets.
Medical Device Documents We Translate
Comprehensive translation support 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
Our translations meet the requirements of major medical device regulations worldwide.
EU MDR (2017/745)
Medical Device Regulation requirements for all 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 for diagnostic devices.
- IVD-specific terminology
- Performance evaluation reports
- Class A-D documentation
FDA Requirements
US Food and Drug Administration device submissions.
- 510(k) submissions
- PMA documentation
- QSR compliance
Other Markets
Global regulatory requirements and market access.
- Japan PMDA / MHLW
- China NMPA
- Health Canada / MDSAP
Frequently Asked Questions
Which EU languages are required for medical device labeling?
EU MDR requires device labeling and IFUs to be provided in the official language(s) of each member state where the device is marketed. This can include up to 24 official EU languages depending on your target markets. We can help you determine the required languages for your distribution strategy.
Do you translate clinical evaluation reports (CERs)?
Yes, we translate clinical evaluation reports and other technical documentation required for EU MDR compliance. Our translators have experience with medical device terminology and understand the regulatory context of these documents.
Can you handle updates to existing IFUs?
Yes, we maintain translation memories and terminology databases for each client to ensure consistency between original translations and updates. This also makes the process more efficient and cost-effective for ongoing IFU revisions.
What is your turnaround time for IFU translation?
Standard turnaround for IFU translation is 5-7 business days depending on document length and number of languages. We offer expedited services for urgent timelines. Contact us with your specific requirements for a customized quote.
Request a Medical Device Translation Quote
Get a customized quote within 24 hours. Our team will assess your requirements and provide a detailed proposal.
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