L4B Software: Your Cornerstone for Embedded Software & OS in Healthcare Technology
Elevating Medical Device Software through Safety, Compliance, and Unparalleled Expertise
In the dynamic healthcare landscape, the role of medical device software has evolved from being functional to critical. L4B Software is your strategic partner, bringing in-depth knowledge and cutting-edge solutions to navigate the complex maze of global regulations, all while ensuring the highest levels of safety and innovation.
Why Choose L4B Software as Your Trusted Partner?
- Regulatory Compliance: A Blend of Expertise and Agility
We specialize in integrating product requirements with complex regulatory frameworks like FDA guidelines, EU’s MDR/IVDR regulations, ISO 13485, and IEC 62304. Regulatory compliance isn’t just about ticking off boxes; it’s our commitment to product quality and patient safety.
- Secure OTA Solutions: Ahead of the Curve
Stay future-ready with our secure Over-the-Air (OTA) solutions that ensure real-time updates and robust cybersecurity, making your medical devices smarter and safer.
- Mastery in Embedded Linux and RTOS
Our unmatched expertise in Linux and Real-Time Operating Systems (RTOS) allows us to provide secure, reliable, and high-performance embedded solutions customized to your medical devices.
- MEDITUX OS™: The Linux SOUP Advantage
We turn Software of Unknown Provenance (SOUP) from a challenge into an asset. Our expertise ensures third-party software components are rigorously evaluated and integrated safely into your medical device systems.
Step into the future of healthcare with L4B’s MEDITUX OS™, a specialized Linux SOUP Subscription Service designed exclusively for medical and healthcare OEMs. Amidst the rapid advancements in medical technology, MEDITUX OS™ emerges as a robust, compliant, and secure operating system. With a cybersecurity-first approach, open source mastery, seamless OTA updates, and a future-ready architecture incorporating AI/ML layers, it’s not merely a Linux subscription; it’s a substantial investment towards assured compliance and technological excellence. With over 20 years of unmatched expertise in Linux, L4B stands as a trusted partner, ensuring a cost-effective, time-saving solution that navigates the complexities of Linux with ease
- MedicDroid™: Pioneering Android Solutions for Medical Devices
Embark on a journey to the forefront of healthcare innovation with L4B’s MedicDroid™, our signature suite of Android-based solutions tailored for the medical device industry. MedicDroid™ leverages the flexibility and ubiquity of the Android Open Source Project (AOSP) to bring intuitive interfaces, expansive connectivity, and a wealth of apps to your medical devices, all while ensuring stringent compliance with healthcare regulations.
- Commitment to Cybersecurity & IEC 62304 Compliance
Our stringent cybersecurity services support series of robustness tests and vulnerability scans, ensuring your medical device software and system is impervious to threats.
L4B supports medical device & Healthcare manufacturers to improve their product lifecycle with Cybersecurity processes in compliance with:
- ISO 81001-5 (Health Software and health IT systems safety, effectiveness, and security – Part 5-1: Security – Activities in the product lifecycle.)
- ISO 62443-4 (Security for industrial automation and control systems – Part 4-2: Technical security requirements for IACS components) with extensions and reviews for safety with:
- IEC 60601-4-5 (Guidance and Interpretation Safety-Related Technical Security Specifications) for risks on data SIPV (security-integrity-privacy-vulnerabilities).
- ISO 14971 with extension of:
- AAMI-57 (Principles for Medical Device Security – Risk Management)
- ISO 80001-1 (Application of risk management for IT-networks for connected medical devices)
Ready to take your medical device software to unparalleled levels of safety, compliance, and performance? Contact us today for a bespoke consultation geared to your unique needs.