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CE Marking (EU MDR/IVDR)
We guide manufacturers through the EU MDR and IVDR certification processes, including compiling Technical Documentation, Clinical Evaluation Reports (CER), and coordinating with European Notified Bodies.
Key Benefits
- Direct access to all European Union member states and EFTA markets
- Comprehensive validation of clinical and technical documentation to meet MDR standards
- Support with Notified Body selection and liaison
Recognized Standards
Our Methodology
1
Classification
Classify device (Class I, IIa, IIb, III) according to Annex VIII rules.
2
Technical File compilation
Prepare safety and performance requirements.
Required Documents
Declaration of Conformity
Clinical Evaluation Report (CER)
Risk Management Dossier
Common Questions
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