Embedded Firmware for Medical Devices (IEC 62304)

Embedded Firmware for Medical Devices (IEC 62304)

Firmware and embedded software for medical devices on STM32, nRF and ESP32 microcontrollers with FreeRTOS or Zephyr, and Yocto Linux on i.MX processors. BLE stacks, update mechanisms, device drivers, signal processing, test software, and Linux or Android porting and optimization. All work follows an IEC 62304 software life cycle, with the documentation written alongside the code so it goes straight into the design history file.

We also take on firmware ports and redesigns for established manufacturers, for example when a component goes end of life or a device moves to a new platform, and we design and document to the security standards FDA expects for health software (IEC 81001-5-1, AAMI SW96, AAMI TIR57).

Part of a full-cycle team of 62 engineers in electronics, firmware and mechanics; ISO 13485:2016 certified quality system; $125 per hour.