Last week, Evnia’s CEO Dr. Efstathios Vassiliadis, and Regulatory Compliance Lead Dr. Vicky Valla, visited Qatar to meet with the team of the Office of Strategic Innovation, Entrepreneurship & Economic Development SIEED of the Qatar University, We had the opportunity to have meaningful interactions with Academics and Researchers from the Biomedical Research Center, Center for Advanced Materials, and QU’s College of Engineering.
Following the presentation of the researchers’ ongoing work, a 2-day session on the regulation of medical devices and in-vitro diagnostics by the FDA was organized in collaboration with QU-Health Cluster. The workshops enabled vivid, productive discussions on how to transit from basic research to the commercialization of innovative healthcare solutions. Focus was on the importance of a quality management system, 21CFR, case-per-case pre-market requirements, the importance of the intended purpose, level, and nature of clinical evidence required for first-in-class products, and postmarket surveillance as an integral part of a medical product’s lifecycle.
The eagerness and commitment to contribute to access to care and healthcare and the development of the healthcare industry by bringing innovative new medical devices and IVDs to the market have been overwhelming.
To further support our cooperation with SIEED, Evnia will deploy ARETI, our customized, 2-arm service for delivering Regulatory and Clinical Excellence in practice. In support of strategic innovation, Evnia will deliver an extensive cluster of regulatory and clinical activities setting the pathway to cover the needs of the entire lifecycle of medical products aiming to accelerate access to the market and enhance patient safety!
Thank you Dr. Mahmoud Abdulwahed Lotfi Belkhir Juha Perälampi Khaled Abouemara Haneen Abdelrazeq !!