IEC 62304 Insourcing for MedTech Companies

Many MedTech startups want to own their firmware and the know-how behind it, but don't yet have the processes or the team to develop medical device software compliantly. With our insourcing service, your company retains full control over its intellectual property while we establish an IEC 62304-compliant workflow, integrate it with your (e)QMS, and help you build an exceptional in-house firmware and software development team.

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An IEC 62304 lifecycle that fits your team

IEC 62304 asks for software development planning, requirements analysis, architectural and detailed design, implementation and unit verification, integration and system testing, release, maintenance, configuration management and problem resolution. How much rigor each activity needs depends on the software safety class of your device.

We set up these processes so they fit your team's size and way of working. That way compliance becomes part of day-to-day development instead of paperwork afterwards.

Connected to your QMS and risk management

Software processes don't stand on their own: they have to be part of your ISO 13485 quality management system and connected to your ISO 14971 risk management file. We integrate software development with your (e)QMS, so requirements, risks, verification and releases stay traceable.

Your team, your intellectual property

The goal of insourcing is that you end up with your own capable firmware and software team. Your company keeps full ownership of its code and intellectual property, and the knowledge stays in-house.

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 are the IEC 62304 software safety classes?

IEC 62304 defines three software safety classes. Class A: no injury or damage to health is possible. Class B: non-serious injury is possible. Class C: death or serious injury is possible. The higher the class, the more lifecycle activities and documentation the standard requires.

Do we keep ownership of the code and intellectual property?

Yes. Our insourcing service is designed so that your company retains full control over its code and intellectual property.

Can you work with the (e)QMS we already have?

Yes. We integrate the software development processes with your existing (e)QMS and ISO 13485 quality management system rather than replacing it.

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.

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Medical 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.