Overview
Multi-disciplined clinical teams provide robust, GCP and ISO 14155 compliant clinical trials for low-risk medical devices.
Expertise
- Medical Devices Clinical Trial Management in Europe
- Biostatistics for Medical Device Clinical Studies
- Medical Devices Clinical Trial Data Management
- Medical Devices Post-Market Clinical Follow-up Studies (PMCF)
- Clinical Research Study Audits of Medical Devices
- Clinical Trial Study Design and Protocol Development of Medical Devices
Advantages
- Cost-effective
- End-to-end Regulatory consultation
- Qualified experts with hands-on experience across all categories of medical devices
- Support for region-specific regulatory complexities
- Interactions with Health Authorities (HAs)
- Structured approach for quick product launch or market access
