--- title: "Medical Device Firmware & Software Consultancy | Compen Embedded" description: "Medical device firmware & software consultancy in Eindhoven, NL. Embedded C/C++ development, IEC 62304 compliance and EU MDR/FDA support for MedTech startups." image: "https://compen.net/og-image.jpg" --- # Compen Embedded – Medical device firmware & software consultancy ## About At Compen Embedded, we understand the unique challenges that startups face in bringing life-changing innovations to market. From navigating regulatory requirements to overcoming technical hurdles, the journey from concept to commercialization can be daunting. That's where we come in. With years of experience and expertise in firmware development, coupled with a deep understanding of the healthcare landscape, we are committed to being more than just a service provider. We are strategic partners, working hand in hand with startups to navigate the complexities of the industry and turn their vision into reality. Our approach is built on collaboration, innovation, and a relentless pursuit of excellence. Whether you're developing wearable monitors, implantable sensors, or cutting-edge medical devices, we have the knowledge, skills, and resources to help you succeed. Join us on a journey of innovation and impact. Together, we can revolutionize healthcare and improve lives around the world. Welcome to Compen Embedded. ### Our Specialized Expertise - Wearable Health Monitors - Implantable Pulse Generators (IPG) - Brain-Computer Interfaces (BCI) - Cutting-Edge Medical Devices _From prototype to regulatory-ready._ ## Services 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. ### Custom 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. - 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 [More about custom firmware development](https://compen.net/services/medical-device-firmware-development) ### Insourcing Services 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. - 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 [More about insourcing services](https://compen.net/services/iec-62304-insourcing) ### Firmware 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. - 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 [More about firmware consultancy](https://compen.net/services/medical-firmware-consultancy) ## Frequently asked questions About medical device firmware, IEC 62304 and working with Compen Embedded. ### 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 We're always interested in hearing from experienced embedded software engineers who want to build firmware for life-changing medical devices. Open application ### Embedded Software Engineer High Tech Campus, Eindhoven · On-site There's no specific vacancy open right now, so send us an open application and tell us what you'd like to work on. [View the open call](https://compen.net/careers) [Apply by email](mailto:info@compen.net?subject=Open%20application%20%E2%80%93%20Embedded%20Software%20Engineer) We're not accepting internship applications at the moment. We'll update this page when that changes. ## Contact Or just drop us an email at [info@compen.net](mailto:info@compen.net) ```json { "@context": "https://schema.org", "@graph": [ { "@type": "ProfessionalService", "@id": "https://compen.net/#organization", "name": "Compen Embedded B.V.", "alternateName": "Compen Embedded", "url": "https://compen.net", "logo": "https://compen.net/icon/96.png", "image": "https://compen.net/og-image.jpg", "email": "info@compen.net", "slogan": "Crafting life-improving medical software", "description": "Compen Embedded provides custom firmware development, IEC 62304-compliant insourcing, and medical device software consultancy for MedTech innovations including wearables, IPG, and BCI.", "address": { "@type": "PostalAddress", "streetAddress": "High Tech Campus 32", "addressLocality": "Eindhoven", "addressCountry": "NL" }, "hasMap": "https://g.page/Compen", "contactPoint": { "@type": "ContactPoint", "contactType": "sales", "email": "info@compen.net", "url": "https://compen.net/#contact", "availableLanguage": [ "English" ] }, "knowsAbout": [ "Medical Device Firmware Development", "Embedded Software", "Embedded C and C++", "Real-Time Operating Systems", "Low-Power Wireless and Bluetooth Low Energy", "Medical Device Software", "IEC 62304", "ISO 14971", "ISO 13485", "EU Medical Device Regulation (MDR)", "FDA Medical Device Regulation", "Medical Device Cybersecurity", "IEC 81001-5-1", "Software Verification and Validation", "Wearable Health Monitors", "Brain-Computer Interfaces", "Implantable Pulse Generators" ], "areaServed": "Worldwide", "hasOfferCatalog": { "@type": "OfferCatalog", "name": "Services", "itemListElement": [ { "@type": "Offer", "itemOffered": { "@type": "Service", "name": "Custom Firmware Development", "description": "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.", "url": "https://compen.net/services/medical-device-firmware-development", "provider": { "@id": "https://compen.net/#organization" } } }, { "@type": "Offer", "itemOffered": { "@type": "Service", "name": "Insourcing Services", "description": "Our insourcing service ensures that your company retains full control over its intellectual property. 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