Clinical Excellence for Medical Devices
NovintiX provides comprehensive clinical affairs services to help medical device companies generate the clinical evidence needed for regulatory approval and market success. Our team brings extensive experience in designing and executing clinical strategies across a wide range of device types.
Our Services Include:
- Clinical Strategy Development - Clinical development planning and regulatory pathway analysis
- Clinical Study Design - Protocol development, statistical analysis plans, and study setup
- Clinical Evaluation Reports - CER development per EU MDR requirements
- Literature Reviews - Systematic literature searches and analysis
- Post-Market Clinical Follow-up - PMCF planning and execution
- Regulatory Submissions - IDE, 510(k), and CE marking clinical support
Why Choose NovintiX?
Our clinical affairs team combines scientific rigor with practical regulatory knowledge. We help you develop efficient clinical strategies that meet regulatory requirements while minimizing time and cost.