Due to the regulations and compliance elements involved with medical device development, the process is expensive, slow and difficult. There are also fewer “off the shelf” tools available to help navigate the process.
During this talk, Sabrina Varanelli, a robotics engineer specializing in surgical robotics and the founder of Nemedio, will help you make sense of what is required when planning to commercialize your medical technology. Topics will include: FDA product classification, regulatory pathways, quality management, and an overview of engineering and compliance activities required for clearance.