Multi-disciplined clinical teams who 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 Device
Clinical Trial Study Design and Protocol Development of Medical Device.
Advantages
Cost-effective
End-to-end Regulatory consultation
Qualified team of experts with hands-on experience across all categories of personal care and cosmetic products like Skincare, Oralcare, Hair care, Baby care and beauty products.
Expert support for region-specific Regulatory complexities
Interactions with Health Authorities (HAs)
Structured approach to ensure quick product launch or market access
