The rise of continually-learning SaMD (software as a medical device) challenges traditional trial models and regulatory frameworks,...
adaptive trials
Trials for Self‑Evolving SaMD present a unique challenge: how to validate, monitor, and regulate software that changes...
Living Algorithms are software systems that continue to learn and adapt after market release; designing continuous real‑world...
The phrase “Regulatory sandboxes for continuous-learning SaMD” captures a powerful new approach to governing software as a...