--- title: "Medical Device Firmware Development | Compen Embedded" description: "Embedded C/C++ firmware for medical devices such as wearables, implantable pulse generators and BCIs. Low-power, wireless and IEC 62304-compliant." image: "https://compen.net/og-image.jpg" --- # 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. [Discuss your project](https://compen.net/#contact) ## 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. ## Devices we specialize in - Wearable health monitors - Implantable pulse generators (IPG) - Brain-computer interfaces (BCI) - Cutting-edge medical devices, from prototype to regulatory-ready ## What we do - 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 [Get in touch](https://compen.net/#contact) or email [info@compen.net](mailto:info@compen.net) ## Frequently asked questions ### 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. ## Other services ### [IEC 62304 Insourcing for MedTech Companies](https://compen.net/services/iec-62304-insourcing) 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. ### [Medical Device Firmware & Software Consultancy](https://compen.net/services/medical-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. ```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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