Foundational Software Solutions for Medical Devices

The QNX OS for Safety and QNX Hypervisor for Safety are certified to IEC 62304 Class C. QNX® Hypervisor for Safety offers the same trusted functionality and performance as QNX® OS 8.0 plus virtualization support. These products are safety-certified variants of QNX OS 8.0 and the QNX Hypervisor, respectively.

Your safety certification process is susceptible to countless deviations. From integration of effective lines of code determined by functional requirements to analysis of vulnerabilities and meeting certification criteria and standards, there are numerous factors that could influence your go-to-market timeline and associated expenses with achieving a safety-certified medical device. Building with a safety certified RTOS eases these processes, allowing you to certify only the components you develop. More benefits of a safety-certified RTOS such as the QNX OS for Safety include:

• Reduced development effort. QNX-documented safety recommendations and restrictions reduce the time and effort (e.g., testing, analysis, documentation) needed for you to develop these materials from scratch—not to mention ensures you design a safe system using these guidelines
• Accelerated time-to-market. The development process can be streamlined to leverage QNX safety artifacts for quicker approvals from regulatory bodies including Class I, II, or III medical devices.
• Maintenance and support. QNX products are maintained and supported throughout the product lifecycle with the utmost rigger, satisfying the medical device update policies required by regulatory bodies and reducing any rework that might be required with regulatory bodies.
• Cost savings. The cost of purchasing safety certification documents can be reduced as it relates to documentation development time and testing efforts. This cost is amplified if there are product updates that require resubmission of documentation.

At the heart of BlackBerry QNX technologies is the microkernel based QNX OS 8.0. The microkernel architecture minimizes downtime, is safe by design, and reduces cyberattack surfaces through isolation and separation mechanisms. Device drivers, Board support packages, and system services run alongside applications, separated from one another and outside kernel space. Running all OS services outside of kernel space enables highly available, fault-tolerant designs—the failure of one application or service will not crash the kernel or other services or applications.

Building on QNX OS 8.0 can help you to develop more resilient and reliable systems.

The frequency of attacks on medical devices and the healthcare sector is rapidly increasing, necessitating proactive measures to ensure connected devices are designed and developed using secure products. Strengthening cybersecurity requires a proactive approach, which includes designing robust secure system architectures, code, and hardware. It is the baseline for integrating security techniques and technologies into medical devices.

BlackBerry QNX solutions provide a layered approach to security that won’t hamper functionality. QNX OS 8.0 comes with a portfolio of security features and reduces attack surfaces by running services outside of the kernel space and provides granular control of system privilege levels, secure boot, and an AES-256 encrypted and self-verifying filesystem.

With the new FDA Cybersecurity requirements and the IMDRF Cybersecurity Guidelines, it’s imperative to build cybersecurity standards-compliant software solutions for medical devices.

QNX® Software Development Platform (SDP) 7.1 is a comprehensive software platform for building medical devices. It includes the latest QNX OS 8.0, QNX® Momentics® Tool Suite and QNX Software Center to provide a full-featured, microkernel RTOS for ARM and x86 platforms with 64-bit support. It also includes a High-Performance Networking stack to support basic-to-complex networking requirements. Its comprehensive POSIX-compliant development environment will be familiar to anyone who’s worked with Linux®.

The microkernel architecture of the QNX RTOS ensures reliable and predictable response times—critical for patient safety in real-time applications. With deterministic scheduling and resource management, QNX can provide consistent processing, reducing latency in vital functions, including:

• Data monitoring (e.g. accurate readings of patient NMT, entropy, EEG, anesthetic-agent measurements, volumetric CO2 and O2, PiCCO, cardiac output, SvO2 and dual SpO2 levels)
• Diagnostics (e.g. precision processing of assays or analyzers to reduce loss of samples from errors and restarts)
• Device control (e.g. low jitter responses to maneuver surgical robotic arms)

This real-time capability helps medical devices maintain precise timing, accuracy, and reliability (fault-tolerant)—all essential for delivering effective healthcare solutions.