26th Expert Session

Medical Device Innovation is driven by emerging technologies and their application across diverse medical fields. Successfully bringing a medical device to the global market requires meeting specific regulatory and technical requirements, as well as demonstrating compliance. This talk offers an overview of regulatory frameworks across various international markets and highlights how to integrate technical requirements into the development and business planning phases of medical device innovation and start-up initiatives. It includes practical examples of processes, documentation, and key considerations for technical safety and performance in device development and testing.