A leading pharmaceutical company in US, wanted to review their Electroporation device firmware code and develop unit tests for the firmware modules.
The Solution consists of:
The company is developing an Electroporation device for delivering plasmid DNA into muscle or skin effectively. Electroporation is the method of applying short-duration high-voltage pulses, on delivering medicine. Pulse sequence and parameters are defined in OP Block (Operation Block), which will be programmed into the device.
Device software is developed on the Cortex M processor(s) in the C++ language. There are two MCUs in the system. One of them using RTX RTOS and other MCU is running on bare metal. The software is developed as a Class C medical device following IEC 62304:2015 and ISO 14971 Risk management standards.