Evnia is a Medical Device and In-Vitro Diagnostics (IVD) Regulatory and Clinical affairs specialist organisation.
Our goal is to help manufacturers accelerate innovation and maintain devices in the European market through reliable regulatory and clinical strategy and implementation under EU/MDR and EU/IVDR.
Evnia has until to date, completed more than 430 clinical evaluation reports (CERs) and supporting technical files, 235 PMCF plans and activities, 92 Regulatory affairs management activities and 80+ Real World Evidence (RWE) activities. We support and trusted by 135 legal manufacturers around the world.
We provide scalable solutions and services for any product portfolios big and small.