Software as a Medical Device (SaMD) is a regulatory compliance section for a standalone software application that executes a medical task. The SaMD category establishes guidelines for medical apps created for use on general-purpose computing devices like smartphones and tablets.
The Food & Drug Administration regulates Medical Device Class (MDC) technology in the United States (FDA). The purpose of creating a SaMD class is to allow programs to meet the same standards of dependability, privacy, and safety as specialized MDC hardware.
At the same time, SaMDs are consumer items and medical devices, and the technological solutions that patients utilize as consumers, and also patient expectations and behaviors, are always changing.
User research informs our iterative design & feedback process, and we leverage product analytics & real-world data to keep the product evolving in times of challenge.