Quality Assurance and Regulatory Affairs

The Quality Assurance and Regulatory Affairs team at AVS is responsible for ensuring that the Pulse IVL System meets stringent safety and efficacy standards throughout its development and commercialization. This team conducts thorough testing, develops and implements quality management systems, and navigates regulatory requirements to ensure compliance with medical device regulations. Additionally, they support clinical trials by overseeing quality controls and documentation, thereby facilitating successful product approval and market entry.