Deterministic execution for safety-critical medical subsystems

MediTUX-RT is a medically governed real-time operating system platform designed for safety-critical and time-deterministic subsystems within regulated medical devices.

It is intended for functions where missed deadlines, uncontrolled latency, or execution starvation can directly impact patient safety, and where long-term regulatory compliance and maintainability are mandatory.

MediTUX-RT is built on Eclipse ThreadX, a mature, permissively licensed real-time kernel governed by the Eclipse Foundation, and is extended by L4B Software with medical-specific integration, risk governance, verification support, and lifecycle management.

Why MediTUX-RT?

Real-time kernels are widely available, and capable engineering teams can integrate them independently.
However, in regulated medical devices, real-time software is rarely just a technical component – it becomes a safety-critical element that must remain correct, deterministic, and auditable over many years of product life. MediTUX-RT exists to address the challenges that arise after the first prototype works, including:

  • Managing timing-related hazards and failure modes
  • Preserving determinism across software changes and updates
  • Supporting IEC 62304 and ISO 14971 activities at the real-time layer
  • Governing security fixes and updates without destabilizing safety behavior
  • Maintaining documentation and evidence across long medical device lifecycles

MediTUX-RT provides a governed real-time foundation so OEMs do not have to own this risk alone.

Typical Medical Use Cases

MediTUX-RT is intended for time-critical medical functions, including:

  • Real-time coordination in robotic and mechatronic medical subsystems
  • Alarm generation and escalation engines
  • Closed-loop control (e.g., infusion, dosing, therapy delivery)
  • Deterministic acquisition and preprocessing of physiological signals (ECG, EEG, SpO₂)
  • Safety supervision and watchdog control in mixed-criticality systems

Deterministic Real-Time Behavior

MediTUX-RT is designed to provide predictable and bounded execution behavior, including:

  • Preemptive, priority-based scheduling
  • Deterministic interrupt handling
  • Bounded latency and jitter characteristics
  • Resource isolation for critical tasks
  • Watchdog integration and fail-safe recovery patterns

The platform can be deployed on 32-bit and 64-bit architectures, including MCUs, safety cores, and dedicated real-time domains within larger SoCs, depending on system design and risk classification.

Optimized for Multicore Architectures (Linux + RTOS)

MediTUX-RT complements MediTUX OS in modern mixed-criticality medical architectures:

  • MediTUX-RT handles hard real-time and safety-critical execution
  • MediTUX OS handles user interfaces, connectivity, data management, AI, and cloud integration

Both platforms can be deployed independently or together as part of a layered medical device architecture.

Security, CVEs & Update Governance

Eclipse ThreadX upstream releases may include security fixes and maintenance improvements as part of their quarterly release cycle. However, like most RTOS ecosystems, Eclipse ThreadX does not operate as a continuously patched distribution with automated CVE feeds.

MediTUX-RT addresses this by providing platform-level security and update governance, including:

  • Tracking of upstream Eclipse ThreadX versions and release notes
  • Assessment of security-relevant fixes for medical impact and timing behavior
  • Controlled platform baselines suitable for regulated environments
  • Support for SBOM generation and vulnerability assessment processes
  • Update decisions aligned with medical device risk management and lifecycle requirements

This approach enables OEMs to demonstrate cybersecurity due diligence while preserving determinism in safety-critical real-time subsystems.

Regulatory Alignment for Class B & Class C Devices

MediTUX-RT is designed to support medical devices containing Class B and Class C software, as defined by IEC 62304, where deterministic real-time behavior and controlled failure modes are critical to patient safety.

The platform provides real-time architectural patterns, SOUP identification, and lifecycle support to assist manufacturers in meeting system-level regulatory requirements, including alignment with:

  • IEC 62304 – software lifecycle processes for Class B/C subsystems
  • ISO 14971 – software-level hazard identification and risk controls
  • IEC 60601-1-8 – alarm timing and reliability considerations (where applicable)
  • IEC 81001-5-1 / FDA cybersecurity expectations – for connected devices

When MediTUX-RT Is the Right Choice

MediTUX-RT is well suited when:

  • Real-time failures could lead to hazardous situations
  • The device includes Class B or Class C software
  • Deterministic timing must be preserved over long product lifecycles
  • Regulatory and quality teams are involved early in architecture decisions
  • Mixed Linux / RT architectures are required

MediTUX-RT is not a generic RTOS. It is a medically governed real-time safety platform designed to help medical device manufacturers manage safety, compliance, and long-term lifecycle risk in time-critical subsystems.

*Note: MediTUX-RT is a platform for safety-critical real-time subsystems.
It is not a certified medical device. Regulatory compliance is achieved at the system level by the manufacturer, supported by platform-level artifacts and services.