We are developing a point-of-care medical device for pathogen detection such as COVID 19. This device is going to need FDA (Food and Drug Administration) approval for EUA (Emergency use authorization). We wrote the firmware on a silicon lab’s ARM-based process (Giant Gecko- EFM32GG) with FreeRTOS. The ARM process will communicate with an Android phone to receive instructions to control the hardware.
Does anyone have any knowledge of how the software (firmware with FreeRTOS) running on a medical device is examined? Will there be any issues with using FreeRTOS?