Evnia is a recognised top compliance consultancy and services provider in Europe.
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.
Our work improves the quality of care and life for patients.
We offer full value chain services in Clinical & Regulatory affairs, our services include Clinical Evaluation Reports, PMCFs, Safety & Performance Clinical Data, Clinical & Technical Documentation and Regulatory Affairs Management.
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.