Sponsors who invested years developing wearable sensors, smartphone-based assessments, or algorithm-driven clinical measures are increasingly receiving FDA...
Predetermined Change Control Plan
For manufacturers of artificial intelligence-enabled Software as a Medical Device (SaMD), the hardest compliance question in 2026...
Software as a Medical Device (SaMD) developers working with artificial intelligence and machine learning components face a...
The rise of continuous‑learning AI and self‑updating digital health tools has forced regulators and manufacturers to rethink...