From AI/ML to smartphones to cloud computing to web services, MedTech faces a growing imperative to leverage these technologies to support the core functions of a regulated medical device. The vendor creating and operating these new technologies have an admirable focus on continuous improvement, but often isn't compatible with MedTech’s traditional approaches to regulated change management.
We can no longer ignore this uncomfortable truth. Instead, we need to adapt to a new set of architectural approaches, best practices, and systems thinking, embracing a more modern approach to device safety and the meaning of the validated state.
Join us to discuss/debate.