At Evnia, our goal is to accelerate innovation in the medical industry in order to bring significant changes to the quality of care and life for patients.
We are a group of like-minded professionals who have unique expertise that enables us to provide a holistic approach to your regulatory compliance in the field of medical devices and in vitro diagnostics.
As our client, you get full access to our in-house regulatory and clinical templates that have a proven success rate during audits. We will support you in bridging the gap between what the regulatory expectations are and what your current state of regulatory documentation is. This will ensure that your innovative design reaches the market faster.
We provide scalable solutions and services for product portfolios big and small.
Implementation of the EU MDR and IVDR requires third country manufacturers to appoint an Authorised Representative in order to market their products in the EU.
Evnia AR is a reliable partner to support you throughout your device’s lifecycle. Our team of Regulatory Specialists and other highly qualified resources has a deep understanding of the regulatory demands for both medical devices and in vitro diagnostics industries and provides tangible results to support your product portfolio.
Our ethos is to help patients, doctors and society through our work. This is why we conduct ourselves honestly, ethically, and with pride – this is our company’s DNA.
As such, Evnia is modeled on the values of integrity, honesty, morality and perseverance to do the right thing.
Evnia is a vital element of the scientific method and the process of addressing any problem on a pragmatic operational level, while focusing on strategic goals.
Evnia (ευ-νοια) is the Greek word for good, smart, articulate thinking.
“ευ” means “good”, while “νοια” means “mind, thinking”.
Evnia requires the skill to create coherent results through detailed knowledge of different disciplines and the process of logically linking facts, data, and information.
It is the basis of our action and the foundation, with which we provide value to our colleagues, clients, patients and, ultimately, the society.
This is the rationale behind our name, and this is what you can expect from us.
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