Medical devices become more complex, so the registration will be more difficult: It impacts design, processes development communication and information.
It should as our lifes depend on it. Time of "just" coding "a" new healthapp is over:"a mobile app that serves as an accessory to support, supplement or augment an existing medical device, or to transform a mobile platform for some form of medical use is now considered an FDA- regulated mobile medical app. The FDA will use the same risk-based approach to ensure the safety and effectiveness of mobile apps that it uses for other medical devices. "..