Evnia was created with only one simple goal in mind, “to ensure that safe and effective medical devices and in vitro diagnostics are available to patients”. In short, ensure that innovative solutions are always safe and effective.
To achieve this goal, Evnia is supporting manufacturers in the following areas of clinical/regulatory and compliance:
1. Clinical Evaluation Reports following MDD/MDR regulations
2. Clinical & Technical documentation related to clinical documentation (Risk/Biocompatibility/Usability/Technical).
3. PMCF plans and execution of Surveys and Clinical Experience data
4. Generation of clinical data and peer review publications in support of devices safety and performance profile.
5. Regulatory affairs management
6. Performance evaluation reports under IVDR
Evnia has an ambitious path to follow and with that constantly in mind we maintain our commitment to support manufacturers in remaining compliant when introducing novel technologies and solutions, and ensure that all products meet patient requirements.
As part of our growth, we now established the Evnia Clinics. Evnia Clinics are primary healthcare centers with 14 medical specialties, aimed to provide first class primary healthcare to patients, while collecting clinical data for the medical devices in use.
Evnia operates in a sector that is inherently vibrant due to constant research efforts, novel technologies, disruptive innovation, market demands and regulatory control. As such we understand that innovation is a multi-disciplinary process stretching far beyond solid knowledge of technology itself.
Evnia is driven by the successful development of innovative, good ideas, it is encoded in our name, Ev-Nia (Ευ-Νοια) translating into smart, articulate thinking in Greek. As such we are devoted in fostering a culture of transparency and educated action by delivering regulatory and compliance solutions that both our clients and ourselves need to succeed.
Patient requirements for a better care and quality of life is a continuous process, a continuum that necessitates to believe in the impossible and remove the improbable. Evnia is devoted to undertake this journey, to strive, to seek, to find answers that can make a difference to patients.
Dr. Efstathios Vassiliadis (Ph.D., MBA, FLC, M.Sc.)
Evnia Group CEO
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