Regulatory-Grade Linux OS for Medical Devices
Cut 6–12 months off your FDA/MDR approval process with a fully managed OS that integrates DevOps, compliance, cybersecurity, and lifecycle support – all delivered as a subscription service
Medical Linux OS platforms are becoming essential as today’s devices are software-driven, connected, and under growing regulatory scrutiny. Recalls are rising, with software now the #1 driver worldwide. Both the U.S. FDA (524B cybersecurity requirements) and the EU MDR/IVDR mandate SBOMs, vulnerability monitoring, post-market surveillance, and secure update lifecycles. Building this infrastructure internally can consume hundreds of thousands of dollars per year in DevOps, compliance, and security resources.
MediTUX OS™ is more than a Linux distribution – it’s a fully managed, regulatory-grade OS service. Each subscription delivers validated OS builds, IEC 62304/ISO 13485 documentation, automated SBOMs, CVE monitoring, and 10+ years of lifecycle updates. With MediTUX, your team can focus entirely on clinical innovation while we ensure your OS foundation is always audit-ready for FDA, MDR, and beyond.
What is MediTUX OS?
MediTUX OS™ is more than an operating system – it’s a Managed OS service. We deliver validated Linux builds, pre-configured compliance documentation, continuous SBOMs, CVE monitoring, and 10+ years of security updates. With MediTUX, the entire OS pipeline – builds, compliance docs, security monitoring, lifecycle support – comes ready-made as part of the subscription.
Accelerate approvals → Pre-validated IEC 62304 documentation
Stay compliant → Continuous CVE monitoring + SBOM generation (FDA 524B ready)
Reduce recall risk → 10+ years of updates and lifecycle patching
Hardware ready → Validated on NXP, TI, Intel, AMD, Xilinx, ST and Nvidia
Why Choose MediTux OS™?
- Cybersecurity First Approach: L4B offers both active and passive cybersecurity services. Your devices are not only defended against current threats but also continuously monitored for emerging vulnerabilities.
- Open Source Compliance & Mastery: Navigate the complexities of FOSS with our in-depth open-source compliance services, ensuring your systems are always up-to-date and legally compliant.
- Extend Your Product Portfolio with MediTUX OS™: Our Linux OS delivers unparalleled versatility across hardware variants, ensuring portability and ease of management for a diverse range of medical devices.
- Unwavering SOUP Support: With detailed SOUP documentation and expert support, L4B ensures that your medical devices adhere to industry standards and best practices.
- Seamless OTA Updates: Keep your devices updated without the hassles. Our OTA support ensures smooth transitions and minimal downtime, maintaining the integrity and functionality of your devices.
- Future-Ready with AI/ML Layers: As the industry moves towards smarter solutions, our Linux SOUP is ready to integrate AI/ML layers, keeping you ahead of the curve.
Accelerate Compliance. Accelerate Launch.
MediTUX Platform helps medical device makers cut 6-12 months off their FDA and EU MDR approval timelines. With built-in cybersecurity, SBOM automation, and pre-validated documentation, you can focus on innovation while we handle compliance.
Startup Path (Pay-As-You-Grow) – Get your Class II/III prototype audit-ready from day one.
Enterprise Path – Scale Class II/III devices with full lifecycle compliance, SLA-backed support, and continuous updates.
Ready to accelerate your submission? Fill out the form and let’s get started.
Take Your Medical Software to the Next Level with MediTUX
Harness the power of secure, certified, and customized medical software solutions. MediTUX delivers reliability, compliance, and innovation for your healthcare projects.
Why Should You build with MediTUX OS™?
Navigating the intricacies of Linux, especially in the critical fields of medical and healthcare, is not a simple task. It’s not just about picking an off-the-shelf Linux solution; it’s about understanding its nuances, ensuring compliance, and maintaining it against the backdrop of constant advancements and ever-evolving threats.
With MediTUX OS™ by L4B, you’re not just purchasing a Linux subscription; you’re investing in:
- Assured Compliance: Our solutions are compliant with IEC 62304, ensuring that your medical devices meet the highest standards of safety and effectiveness. Our engineering processes also boast ISO13485 certification, guaranteeing quality and consistency in our deliverables.
- Commitment to Cybersecurity: Our stringent cybersecurity services support series of robustness tests and vulnerability scans, ensuring your medical device software and system is impervious to threats. MediTUX OS Premium subscription complies with ISO 81001-5, ISO 62443-4, AAMI-57, ISO 80001-1.
- 20+ Years of Proven Safety-Critical Software Delivery: Our legacy spans over 20 years in the Linux domain, offering a depth of understanding that’s unrivaled in the industry.
- Cost-Effective & Time-Saving: Managing Linux in-house or opting for an un-maintained Linux version might seem cost-effective initially but can lead to potential risks and unforeseen expenses in the long run. Our subscription ensures peace of mind and potentially saves costs tied to system failures, non-compliance, or cyber threats.
Supported Embedded Platforms
MediTUX supports a range of processor families that are commonly adopted in regulated medical devices.
This ensures customers can build on long-lifecycle silicon platforms, while MediTUX delivers the regulatory-grade OS, compliance documentation, and long-term security updates required for safety-critical software development.
| Vendor / SoCs | Typical Medical Applications | Market Adoption |
|---|---|---|
| NXP (i.MX6–i.MX9) | Infusion pumps, patient monitors, imaging consoles | Widely used in Class II/III devices |
| STMicro (STM32MP1, STM32H7) | Portable diagnostics, MCU–Linux bridge | Adopted in portable diagnostics & wearables |
| TI Sitara (AM335x, AM62x, AM64x, AM65x) | Ultrasound, diagnostic carts, HMI | Strong history in imaging & monitoring |
| Intel (Atom, Celeron, Core i3–i9) | Imaging systems, surgical navigation, GUI consoles | Widely adopted in imaging & surgical platforms |
| Xilinx (Zynq-7000, Ultrascale+ MPSoC) | Surgical robotics, FPGA-accelerated imaging | Used in surgical & imaging devices |
| NVIDIA Orin (Jetson AGX/NX, IGX Orin, Clara Holoscan) | AI endoscopy, surgical robotics, real-time imaging | Deployed in AI-assisted medical platforms |
| Raspberry Pi (Pi 4 / Pi 5) | PoC, prototyping, demos | Popular for evaluation; not suitable for clinical production |
👉 Not sure which program fits your team best?
Schedule a 30-minute session with our specialists to explore your eligible licensing path.
About L4B: Your Trusted Linux Partner
At L4B, we’re not just another Platform provider. We’ve delivered embedded Linux in industries where failure is not an option – from automotive to healthcare. That legacy now powers MediTUX OS™, your compliance foundation for next-generation medical devices. With two decades of hands-on experience, we pride ourselves on being genuine Linux experts. From the intricacies of bootloaders to the nuances of sophisticated applications, our depth of understanding spans the entire Linux ecosystem. This comprehensive knowledge is further enriched by our advanced skills in cybersecurity and profound insight into open-source methodologies. Trusting us means collaborating with a team that’s been at the forefront of Linux advancements, ensuring that your solutions are built upon a foundation of unmatched expertise and dedication to excellence.
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