Embedded systems can include microcontrollers or microprocessors running custom firmware with or without operating systems. Many instruments these days involve multiple embedded controllers communicating over networks such as CAN, Ethernet, or I2C.
Embedded systems are responsible for real-time automation of instrument functions, digital sampling, data analysis, self-test/calibration, and cloud connectivity. Embedded hardware often involves custom printed circuit board assembly (PCBA) design developed in close coordination with firmware development.
We have developed numerous embedded control solutions for medical instrumentation and life science automation, with specific experience in:
- C/C++ firmware development
- Qt Framework and Qt/QML touchscreen UI development
- Microcontroller & DSP Architectures: STM32 ARM Cortex, Atmel AVR, Microchip PIC, Renesas M16C, TI TMS320 DSP, Arduino
- Toradex, Variscite, and Raspberry Pi SoMs (System-on-Modules)
- Embedded Linux solutions (Toradex Torizon, Yocto, and Raspbian)
- Over-the-air (OTA) strategies for software updates and remote monitoring
- Custom mixed-signal PCBA design, including carrier boards for SoMs designed for custom form factors
- ISO 62304 (medical software lifecycle management), ISO 14971 (medical device risk management), and FDA guidance for medical device software
- Communication standards for industrial automation (EtherNet/IP)
For medical devices, special attention must be paid to safety and risk assessment in software that is included as part of a medical device. This includes firmware. We are conversant in ISO 62304 and FDA regulations regarding software lifecycle management, verification/validation, risk management per ISO 14971, and FDA documentation for medical device software. We have experience developing debugging interfaces and automated test solutions for medical devices. We will work within your quality system to ensure your software is suitable for regulatory submission.
