FastFocus, a medical device manufacturer with roots in dairy sensor technology, developed the FastFocus Wireless Patient Monitoring System featuring the EarSensor device for remote patient monitoring in hospitals and home care. Classified as a Class 2 medical device under IEC 62304, the EarSensor software was built in C11 using MinGW GCC within the IAR Embedded Workbench 8.0 environment and runs on an NXP ARM Cortex M4 processor. To meet IEC 62304 compliance, FastFocus needed an embedded unit‑test framework that ensured safety, reliability and adherence to medical software development standards.

Join for free to read