Embedded Software in Healthcare
26bitz builds embedded software for medical devices — the low-level code that runs directly on hardware, controlling sensors and making real-time decisions without a cloud round-trip. We handle firmware and the systems that connect it to hospital IT, built to IEC 62304, ISO 13485, FDA QMSR, and EU MDR standards.
Seamless System Integration for Medical Hardware
From diagnostic tools to implantable devices, the success of medical technology depends on flawless interaction between software and hardware. We design embedded systems that:
Process real-time health data without delay
Connect seamlessly with hospital infrastructure & cloud platforms
Meet global compliance standards from day one
Performance & Compliance, Engineered Together
A powerful embedded system isn’t just about performance—it’s about meeting the strictest healthcare regulations without slowing down innovation. That’s why we build every solution with safety, security, and scalability in mind, ensuring compliance with:
IEC 62304 for medical software life cycle processes
ISO 13485 for quality management in medical devices
FDA QMSR & EU MDR for regulatory readiness
Intelligent Firmware for Smarter Devices
Embedded systems should be fast, energy-efficient, and secure. Our custom firmware solutions ensure:
Optimized power consumption for longer battery life
Fail-safe software updates & remote patches
Seamless connectivity with BLE, Wi-Fi, or proprietary protocols
Cybersecurity at the Core
When patient data is at stake, there’s zero margin for error. Every line of code we write is built with cybersecurity in mind, ensuring protection against data breaches, unauthorized access, and system failures.
✔ End-to-end encryption for secure data transmission
✔ Real-time threat monitoring & intrusion detection
✔ Failover mechanisms to prevent downtime
Beyond Launch: Continuous Optimization & Support
A medical device isn’t a one-time project—it’s a living system that evolves. We provide:
Proactive monitoring to catch issues before they happen
Regulatory updates to keep your device market-ready
Scalability for future software & hardware upgrades
FAQs
Find answers to your most pressing questions about our healthcare software solutions.
It's the software running directly on the device's hardware — controlling sensors, processing signals, managing power, and often making real-time decisions with no cloud round-trip. If the device does something on its own without waiting for an app or server, that's embedded software.
Both. We build the low-level firmware that talks to sensors and hardware, and the higher-level software that connects your device to hospital IT systems, apps, or the cloud. Most of our clients need both layers working together, not just one.
Yes! We regularly integrate with existing sensors, PCBs, and device hardware rather than starting from scratch. We'll assess your current stack first and tell you honestly what's reusable and what needs rework.
Through a defined post-market process: version control, regression testing against your risk file, and documentation that satisfies your regulatory pathway's change-control requirements. Updates on a regulated device aren't just a push to production — we treat them as their own mini-lifecycle.
Yes — we built a portable stabilometric platform for two orthopedic clinics: a custom balance board with an integrated accelerometer and Wi-Fi connectivity, paired with desktop software for real-time diagnostics and rehab tracking. It runs offline, on battery, and includes a gamified mode to keep pediatric patients engaged during rehab.
Schedule a consultation with our team
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