Sahana Roopkumar

Overcoming technical barriers and building path-breaking devices is simply not sufficient to create a safe, compliant and successful medical device. Several devices have not made it to the market despite being technically feasible, primarily because quality management system has not been incorporated in the early stages of device development, or the developer is unaware of the importance of regulation and quality assurance on a path towards commercialization. Quality assurance and Regulatory Science has become quintessential and a fundamental characteristic of today’s healthcare industry. It encompasses the current science practices with legal and business issues. In this exciting times of medical device development and clinical trials, there is an urgent demand to get the functionality right. My aim is to play a critical role within an organization, providing operational and tactical support to fasten the development and yet ensure delivery of safe and effective healthcare products to people around the world.