Presenter

Vivek Thakkar is a seasoned Regulatory Affairs and Quality Assurance professional with a Master's Degree in Medical Device and Diagnostic Engineering. With 15 years of expertise in the field, Vivek specializes in guiding teams through FDA submissions and establishing Quality Management Systems (QMS) for software-based medical devices (SaMDs). His passion for simplifying complex processes and his dedication to advancing healthcare technology have made him a trusted advisor in the industry, particularly for emerging AI-ML driven SaMDs. Vivek's work contributes to safer, more effective, and user-friendly digital health solutions.