21/08/2026
Software as a Medical Device 📱
Not all healthcare apps are medical devices. Software as a Medical Device, or SaMD, is software designed to perform a medical function without being part of a hardware medical device.
Because it is not tied to dedicated hardware, it can run on a smartphone, tablet, or computer. In other words, the medical function is performed by the software itself, while the device serves as the platform on which it runs.
Smartphone-based SaMD is the type of technology BlinkLab is developing. Because SaMD is intended for medical purposes, it must meet applicable medical device requirements and, where required, undergo regulatory review.