At Evnia, we enable manufacturers that develop medical and in-vitro diagnostics devices worldwide to remain in compliance with regulatory standards in clinical, IVD, and technical documentation requirements to ensure their audit and inspection readiness.
We offer full value chain services in Clinical & Regulatory affairs, our services include
- Regulatory Affairs Management
- Clinical Evaluation Reports
- PMCF
- Real World Evidence / Safety & Performance Clinical Data
- Clinical & Technical Documentation
- EU- Authorized Representative
- UK- RP
Evnia’s cross-functional team of experts includes Medical Writers, Medical Doctors, Biocompatibility Experts, and Engineers for Usability, Risk & Validation. This allows us to ensure a comprehensive assessment of the device’s safety and performance profile and bridge the gap between what notified bodies expect and what you currently have in your regulatory documentation.
