Medical Device Firmware Development
Compen Embedded develops custom firmware for medical devices: the embedded software that runs on the microcontroller inside wearable health monitors, implantable pulse generators, brain-computer interfaces and other MedTech products. From the first prototype to a regulatory-ready release, we write firmware that is reliable, power-efficient and developed according to IEC 62304.
Discuss your projectFirmware built for regulated medical devices
Firmware in a medical device has to meet far stricter requirements than firmware in consumer electronics. IEC 62304 requires a defined software lifecycle, from requirements and architecture through verification, release and maintenance, scaled to the software safety class. ISO 14971 requires software-related risks to be identified and controlled.
We build these requirements into development from the start, so your firmware and its documentation grow together and you don't have to reconstruct evidence just before a regulatory submission.
Low-power and wireless by design
Wearables and implantables often have to run for a long time on a small battery while communicating over Bluetooth Low Energy or other wireless links. We design firmware with power consumption in mind from the beginning, on RTOS-based or bare-metal microcontroller architectures, so your device stays reliable and efficient in the field.
Tested and verified
Reliable medical firmware needs evidence, not just good intentions. We use unit testing, static analysis and hardware-in-the-loop testing, and produce the verification and validation documentation you need for your technical file.
Devices we specialize in
- Wearable health monitors
- Implantable pulse generators (IPG)
- Brain-computer interfaces (BCI)
- Cutting-edge medical devices, from prototype to regulatory-ready
Frequently asked questions
Which programming languages do you use for medical device firmware?
We develop medical device firmware in embedded C and C++, on RTOS-based or bare-metal microcontroller platforms.
Can you develop firmware for implantable medical devices?
Yes. Implantable pulse generators (IPG) and brain-computer interfaces (BCI) are among our specializations, alongside wearable health monitors.
Is the firmware developed according to IEC 62304?
Yes. We develop and document firmware according to IEC 62304, with software risk management in line with ISO 14971, so it can be part of your EU MDR technical file or FDA submission.
Other services
IEC 62304 Insourcing for MedTech Companies
Our insourcing service ensures that your company retains full control over its intellectual property. We will establish a compliant and efficient workflow in accordance with IEC 62304 standards, assist with the integration of your (e)QMS, and help you build an exceptional in-house firmware and software development team.
Learn moreMedical Device Firmware & Software Consultancy
We provide specialized medical firmware consultancy, helping healthcare innovators develop secure, compliant, and high-performance solutions. We ensure your medical devices meet industry standards, from FDA regulations to ISO certifications, while optimizing firmware for precision and reliability.
Learn more