# Compen Embedded > Compen Embedded is a medical device firmware and software consultancy based at the High Tech Campus in Eindhoven, the Netherlands. We help MedTech startups and innovators worldwide develop safe, reliable embedded software and bring it to market in line with IEC 62304, ISO 14971, EU MDR and FDA requirements. Compen Embedded positions itself as a strategic partner rather than just a service provider: it works hand in hand with startups on both the technical hurdles and the regulatory requirements of bringing medical devices to market, from prototype to regulatory-ready. ## Services - [Medical Device Firmware Development](https://compen.net/services/medical-device-firmware-development.md): Embedded C/C++ firmware for medical devices such as wearables, implantable pulse generators and BCIs. Low-power, wireless and IEC 62304-compliant. - [IEC 62304 Insourcing for MedTech Companies](https://compen.net/services/iec-62304-insourcing.md): Keep your IP in-house: we set up an IEC 62304 software lifecycle, connect it to your ISO 13485 QMS and ISO 14971 risk management, and help build your team. - [Medical Device Firmware & Software Consultancy](https://compen.net/services/medical-firmware-consultancy.md): Expert advice on medical device software: IEC 62304, ISO 14971, ISO 13485, EU MDR and FDA documentation, and cybersecurity to IEC 81001-5-1. ### Medical Device Firmware Development Page: https://compen.net/services/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. - Embedded C and C++ firmware for medical devices - RTOS-based and bare-metal software on microcontrollers - Ultra-low-power, battery-powered designs with Bluetooth Low Energy and wireless connectivity - Firmware for wearable health monitors, implantable pulse generators (IPG) and brain-computer interfaces (BCI) - Unit testing, static analysis and hardware-in-the-loop testing, with verification and validation documentation #### Firmware 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. **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. ### IEC 62304 Insourcing for MedTech Companies Page: https://compen.net/services/iec-62304-insourcing 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. - Setting up an IEC 62304 software development lifecycle that fits your team - Integrating software processes with your ISO 13485 quality management system and (e)QMS - Software risk management in line with ISO 14971 - Helping you build and grow your own in-house firmware and software team - Your company keeps full ownership of its code and intellectual property #### 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. **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 & Software Consultancy Page: https://compen.net/services/medical-firmware-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. - Medical device software compliance with IEC 62304, ISO 14971 and ISO 13485 - Software documentation for EU MDR technical files and FDA submissions - Medical device cybersecurity following FDA premarket guidance and IEC 81001-5-1, including SBOMs - Verification and validation strategy for embedded software - Optimizing firmware for precision, reliability and low power consumption #### Regulatory 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. **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. ## Specialized expertise - Wearable health monitors - Implantable pulse generators (IPG) - Brain-computer interfaces (BCI) - Cutting-edge medical devices, from prototype to regulatory-ready ## Frequently asked questions ### What does a medical device firmware consultant do? 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. ### What is IEC 62304 and how can you help us comply? 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. ### Which regulations and standards do you work with? 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. ### What kind of medical devices do you develop firmware for? 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. ### Do you work with startups outside the Netherlands? Yes. We are based at the High Tech Campus in Eindhoven, the Netherlands, and support MedTech startups and innovators worldwide. ### Who owns the firmware and intellectual property? 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. ## Careers Page: https://compen.net/careers (Markdown: https://compen.net/careers.md) We're always interested in hearing from experienced embedded software engineers who want to build firmware for life-changing medical devices. There's no specific vacancy open right now, so send us an open application and tell us what you'd like to work on. - Position: Embedded Software Engineer (Open application), High Tech Campus, Eindhoven ยท On-site - This is an on-site role. To be considered, applicants must currently reside in the Netherlands and hold valid work authorization. - How to apply: Send your CV and a short motivation to info@compen.net, and tell us about the embedded work you're most proud of. - Internships: We're not accepting internship applications at the moment. We'll update this page when that changes. - Recruiters: Compen Embedded does not accept unsolicited resumes from third-party recruiters. Should we engage with unsolicited resumes, we will not be liable for any associated fees. ## Contact - Email: info@compen.net - Contact form: https://compen.net/#contact - Address: High Tech Campus 32, Eindhoven, The Netherlands - Chamber of Commerce (KvK): 92505643 ## Optional - [Cookie policy](https://compen.net/cookies): The website uses no tracking cookies and no third-party tracking services.