--- title: "Medical Firmware & Software Consultancy | Compen Embedded" description: "Expert advice on medical device software: IEC 62304, ISO 14971, ISO 13485, EU MDR and FDA documentation, and cybersecurity to IEC 81001-5-1." image: "https://compen.net/og-image.jpg" --- # Medical Device Firmware & Software 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. [Discuss your project](https://compen.net/#contact) ## 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. ## 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 - 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 [Get in touch](https://compen.net/#contact) or email [info@compen.net](mailto:info@compen.net) ## Frequently asked questions ### 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. ## Other services ### [Medical Device Firmware Development](https://compen.net/services/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. ### [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. 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