IVDR & MDR Translation Services
Our IVDR Translation Services
In Vitro Diagnostic Device Documentation:
- IFU Translation – Instructions for Use for all device classifications
- Labelling Translation – Device, packaging, and transport labels
- Technical Documentation – Regulatory submission files
- Summary of Safety & Performance (SSP) – Class C & D device requirements
- Post-Market Surveillance – Ongoing compliance documentation
IVDR Compliance Support:
- Translation into all official EU languages
- Terminology consistency across device portfolios
- Quality assurance for regulatory acceptance
- Updates for evolving IVDR requirements
Our MDR Translation Services
Medical Device Documentation:
- CE Marking Documentation – Complete regulatory file translation
- Clinical Evaluation Reports – Specialist medical translation
- Risk Management Files – ISO 14971 documentation
- Quality Management Systems – ISO 13485 compliance materials
- Declaration of Conformity – Regulatory submission documents
MDR Documentation Translation
- All medical device risk classifications
- Notified Body submission materials
- Post-market clinical follow-up documentation
- Authorised representative files
Planning your MDR Translation? Try our online MDR Translation Compliance Checklist. You can track and download your planning and progress.
Request a Medical Translation Quote