Medical device firmware & software consultancy

A medical device firmware consultant designs, develops and reviews the embedded software that runs on a medical device, and makes sure it is developed and documented according to the regulations that apply to it. At Compen Embedded we combine hands-on embedded C/C++ development with experience in IEC 62304, ISO 14971, ISO 13485, EU MDR and FDA requirements, so your firmware is both technically sound and ready for regulatory review.

IEC 62304 is the international standard for the software lifecycle of medical devices. It defines how software must be planned, specified, designed, tested, released and maintained, depending on its safety class. We set up an IEC 62304-compliant development workflow, integrate it with your (e)QMS and ISO 14971 risk management, and help your team apply it in day-to-day work.

We work with IEC 62304 (medical device software lifecycle), ISO 14971 (risk management), ISO 13485 (quality management systems), the EU Medical Device Regulation (MDR), FDA requirements, and medical device cybersecurity guidance including the FDA premarket cybersecurity guidance and IEC 81001-5-1.

We specialize in wearable health monitors, implantable pulse generators (IPG), brain-computer interfaces (BCI) and other cutting-edge medical devices, typically low-power, battery-powered and wirelessly connected, from prototype to regulatory-ready.

Yes. We are based at the High Tech Campus in Eindhoven, the Netherlands, and support MedTech startups and innovators worldwide.

You do. Our insourcing service is designed so that your company retains full control over its code and intellectual property, while we help you build the processes and in-house team to develop it.