Device and healthtech innovation is prone to getting ahead of regulation. The arrival of artificial intelligence as a medical device (AIaMD) is testing processing capacities to the limit, which is where pre-determined change control plans (PCCP) can serve a useful purpose.
AI/machine learning technological advances will continue to challenge regulatory systems around the world,
“The highly iterative, autonomous and adaptive nature of highly adaptive tools require a new total product life cycle regulatory approach to check for improvement as well as performance deteriorations,”
