Research

Avazzia is committed to the ongoing support of evidence-based research to improve patient outcomes. Our electrical stimulation (e-stim) technology is actively used in clinical research studies within renown academic centers and hospitals across the globe. Clinicians and researchers, representing numerous specialties, routinely publish outcomes data in peer-reviewed journals and present their findings at medical conferences.

Clearances

Bringing innovative medical devices to markets around the world requires carefully navigating complex regulatory requirements that can vary significantly between countries and regions. Before being approved for sale and use on patients, our medical devices must undergo thorough review processes to ensure they meet the highest standards for safety and efficacy. Depending on the device classification and intended uses, Avazzia must obtain clearances or certifications from governing bodies like the U.S. Food and Drug Administration (FDA), European Union’s Medical Device Regulation, Health Canada, and many other regional and country-specific authorities.

Achieving these critical certifications involves providing comprehensive documentation, clinical data, quality system adherence, and potentially an on-site audit to validate our device’s design, manufacturing, and ability to perform as labeled. With clearances being valid only within each regulatory jurisdiction, Avazzia must be prepared to repeat this rigorous process across multiple geographies to make our products available globally.