The process of developing a revolutionary medical device from the proof-of-concept stage to the marketing stage is expensive and complicated. The creation of a new product is a costly and time-consuming endeavour. Demonstrating the safety and efficacy of the technology is just as crucial as the innovation itself. Deeksha K S, et all at JSS College of Pharmacy, discusses why these requirements can assist you to update your development operations and create a product that fulfils the regulatory standards of a safe and effective product for its intended application.