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Foundational Software Solutions for Medical Devices

Streamline safety certification and enhance device security with BlackBerry QNX software and solutions.
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Deliver Secure, Safety-Certified Medical Devices with BlackBerry QNX

Deliver Secure, Safety-Certified Medical Devices

Whether you’re building a new product, a new prototype, or retooling an existing product, BlackBerry® QNX® software is trusted by medical device manufacturers to support a broad range of life-critical and graphics-rich medical devices. Our foundational software is time-tested, inherently secure, and purpose-built for embedded systems. We pre-certified our QNX® OS for Safety and QNX® Hypervisor for Safety products to IEC 62304 Class C, and have launched QNX OS for Safety in the Cloud to help optimize your product lifecycle.

Download our Medical Solutions Guide to learn how BlackBerry QNX can help you with your medical applications.

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Healthcare Benefit from BlackBerry QNX

How Healthcare Can Benefit from BlackBerry QNX

Healthcare systems around the world are facing pressures due to tightening budgets, growing patient expectations and demands, and rising global health expenditures. As these trends continue, the need for automation and connectivity is driving a new generation of medical devices that are technologically more complex and smart. Leading the advanced technology evolution is BlackBerry QNX, providing manufacturers with the necessary foundational software needed to build safe, secure, and reliable medical devices.
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a decorative image of QNX delivers foundational software

Foundational software that:

  • Is safety-certified and has a secure microkernel architecture that is trusted by leading medical device manufacturers.
  • Is standards-based and works across safety and non-safety related systems and is scalable across medical device products and product lines and families.
  • Has adaptive partitioning and prioritization scheduling to help ensure critical processes get the cycles they need to complete tasks on time.
  • Enables granular security profiles and the ability to monitor and audit for system integrity.

Keep Your Medical Device Safe and Secure

Build with standards-compliant foundational software that can help accelerate certification of IEC 62304 up to Class C.

Ensure Reliability

Limit medical device down time and leverage temporal and spatial isolation mechanisms such as adaptive partitioning. Build on BlackBerry QNX microkernel architecture that has supported hundreds of millions of mission-critical systems for decades without failure.

Strengthen Cybersecurity

Leverage microkernel architecture designed with embedded security features. Use our experts to uncover software vulnerabilities in third-party and open-source components. And harden devices with anti-counterfeiting and product authentication cybersecurity solutions with PKI, AMS, and more.

Reduce Costs

Reuse application and driver code across devices and product lines without needing to maintain an open-source OS. Limit hardware costs by virtualizing multiple OSes on an SoC. And decrease development lifecycle with a pre-certified commercial OS.
QNX Cybersecurity for Medical Devices

Cybersecurity for Medical Devices: Building Standards-Compliant Software Solutions

Download “A Prescription for Security: Mitigating Cybersecurity Threats in Medical Device Software” to learn about strengthening cybersecurity and how it applies to global medical regulations.
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Need More Information?

Download “5 Criteria to Consider When Choosing a Medical Device OS” to learn about:

1.      Safety certification

2.      Code traceability and software of unknown provenance (SOUP)

3.      OS architectures

4.      Cost and time-to-market

5.      Long-term support and complete lifecycle licensing

Medical Webinar Series

Shortening Medical Software Development

In this webinar—the first in our series of three focusing on medical device software development—our experts discuss how to develop safe, secure medical devices.

The Importance of Strong Cybersecurity Principles

This second webinar in our series addresses establishing practices to ensure the security of components from your complex supply chain that can include COTS and SOUP.

Streamlining Safety Certifications in Medical Devices

Learn how to speed up your medical development process while demonstrating the safety of your device in the third webinar in our series.

Machine Learning in Medical Devices

How will you incorporate future-looking technology into development of your safety-critical medical devices? What if your software produces unintended outcomes? Get answers and learn how to strengthen the protection of your patients and users with safeguards to address potential impacts of algorithmic updates by watching this webinar. 

Meet with BlackBerry QNX Functional Safety Experts and Get Help with Your Next Certification or Safety-Critical Project.

Related Solutions

QNX OS for Safety

Pre-certified to IEC 62304, QNX OS for Safety is a microkernel RTOS ideal for building life-critical devices.

QNX Hypervisor for Safety

Pre-certified to IEC 62304, QNX Hypervisor for Safety allows for mixed criticality of multiple OSes to safely co-exist on the same SoC.

Professional Services

With deep expertise in functional safety and cybersecurity, the BlackBerry QNX team can help you build secure systems.

Additional Resources

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Trey the QNX Software Development Platform for free with our 30-day evaluation license.
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Software certified to the most stringent functional safety standards.
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View our extensive library of BSPs for a board selection of ARM and x86 boards.
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FAQs about QNX for Medical Device Software

Which QNX products are safety-certified to IEC 62304 standard?

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.

What are the benefits of a safety-certified RTOS?

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.

What advantages does the microkernel architecture offer?

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.

How does the RTOS help strengthen cybersecurity for medical devices?

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.

How easy is it to develop with QNX OS 8.0?

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®.

What are the real-time performance advantages of QNX RTOS for medical devices?

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.