Medical Device Firmware & Software Consultancy
Need an experienced partner to get your medical device software right? Compen Embedded provides specialized medical firmware consultancy, helping healthcare innovators develop secure, compliant and high-performance solutions that meet industry standards, from FDA regulations to ISO certifications.
Discuss your projectRegulatory compliance for medical device software
We help you apply IEC 62304, ISO 14971 and ISO 13485 to your firmware and software, and prepare the software documentation for your EU MDR technical file and FDA submissions, so regulatory review doesn't hold up your launch.
Medical device cybersecurity
Connected medical devices are expected to be secure by design. The FDA's premarket cybersecurity guidance and IEC 81001-5-1 set expectations for secure development practices, security risk management and a software bill of materials (SBOM). We help you build these into your firmware and your documentation.
Verification, validation and optimization
We help you define a verification and validation strategy for your embedded software, and optimize firmware for precision, reliability and low power consumption.
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
What is IEC 81001-5-1?
IEC 81001-5-1 is the international standard for security activities in the product lifecycle of health software, including medical device software. It complements IEC 62304 by adding cybersecurity requirements to the software lifecycle.
What is an SBOM and why does the FDA ask for it?
A software bill of materials (SBOM) lists the software components in your device, including third-party and open-source libraries. The FDA expects an SBOM in premarket submissions for cyber devices, so vulnerabilities in those components can be identified and managed over the device's lifetime.
Can you help with EU MDR and FDA submissions?
Yes. We help prepare the software documentation for EU MDR technical files and FDA submissions, in line with IEC 62304, ISO 14971 and the applicable cybersecurity requirements.
Other services
Medical Device Firmware Development
With over a decade of experience in custom firmware development across various industries, Compen Embedded specializes in delivering high-quality, reliable software tailored to meet the stringent requirements of highly regulated environments.
Learn moreIEC 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.
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