Smita Kundu

- Performing regulatory assessments on existing SaMD and updating device registrations - Post Market Surveillance activities including regulatory evaluation of reportability for customer complaints - Performing QMS internal audits according to MDSAP Audit Approach - Participating and presenting during external audits - Creating and updating technical documentation

Dataset annotation for microgravity experiments with granular gases using a Python GUI for image tracking

- Handling sales for numerous accounts from the eastern and north-eastern regions of India - Providing quality technical expertise to physicians and other support staff about the intended use and deployment technique of products in the cathlab - Participating in health symposiums for physicians, organising training events for physicians to learn newer therapies - Managing logistics

- Observing different types of cardiac surgeries (coronary artery bypass grafting, heart valve repair and replacement procedures) and reporting the observations - Gaining technical expertise in artificial heart valves therapies - Conducting a survey with 50 cardiovascular surgeons about their opinions on the need to treat secondary tricuspid valve regurgitation and their preferred mode of treatment

Focus on medical device regulatory affairs