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Medical Device Operating System

Streamline safety certification and accelerate new product introductions with BlackBerry QNX

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QNX Embedded OS for Medical Devices

Certifying a safety-critical medical device built on Linux® can be much more difficult than many developers anticipate, significantly delaying product launch dates. Plus, maintaining open source operating systems and drivers can monopolize the time of your best developers, preventing them from working on new features or innovations. All of these increase your development costs and magnifies the burden of device testing and certification.

Get medical devices to market faster while ensuring they are safe, secure and reliable over the entire product lifecycle with the right embedded real-time OS.

BlackBerry® QNX® offers a broad range of safety-certified and secure embedded software solutions, complemented by world-class engineering services, to help medical device developers ensure system reliability, accelerate time-to-market and reduce development costs. 

What You Need

Safety certification is a huge burden – and an almost insurmountable challenge if you use software of unknown provenance (SOUP), such as Linux. In addition, medical devices need to boot up quickly, never crash and ensure that the highest-priority applications run first. Using a safety-certified OS or hypervisor can significantly reduce the complexity, cost and length of your embedded system certification processes – and ensure the performance you need. 

QNX® OS for Safety is assessed by TÜV Rheinland to be suitable for use in applications requiring IEC 62304 compliance up to Class C. BlackBerry QNX solutions are built with a focus on safety and the real-time determinism needed for safe medical systems. 

Device failure is not an option when you are designing a life-saving medical device. Unfortunately, you can’t schedule or prioritize critical functions in a monolithic kernel OS, and a problem with a driver or application can crash the whole system, reducing reliability and potentially creating a life-threatening situation.

The QNX microkernel architecture and separation mechanisms, such as adaptive partitioning, ensure unmatched reliability for your device. QNX® Hypervisor for Safety allows you to consolidate multiple operating systems on a single system-on-chip (SOC) to provide flexibility. 

A pre-certified real-time operating system (RTOS) can help medical device manufacturers get to market faster and with less risk of non-compliance. While Linux is popular for prototypes, compliance with IEC 62304 is more complex and costly with an open source OS.

BlackBerry QNX products are POSIX-compliant, so you can port easily from Linux to QNX OS at any point in your software development lifecycle. Developers ramp up quickly on QNX OS, as it looks and feels like Linux, and uses the same tools, such as the GNU compiler collection (gcc). Plus, BlackBerry QNX offers board support packages (BSPs), and QNX experts can help streamline your development timelines.

The breach of a medical device or device communications can put customers, patients and your company at risk, so security needs to be built-in across the entire system, including your OS. In addition, your medical device may need to operate successfully on an IEC 80001-conformant healthcare IT network.

With an advanced and secure embedded RTOS for mission-critical systems, BlackBerry QNX solutions provide a layered approach to security that won’t hamper functionality or performance. For example, there are more than 70 options to restrict what each process can do, and root-level access is removed by default. In addition, secure over-the-air (OTA) software updates, a secure supply chain, managed PKI authentication, FIPS-certified encryption, and cybersecurity services provide you with essential building blocks to create a secure device. 

If your organization has many product lines, reusing application and driver code across devices and lines of business can allow you to scale your software development program to deliver new product introductions (NPI) faster – and drive more revenue.

When you use the QNX microkernel RTOS and QNX software stack across product lines, you can offload OS maintenance to QNX while sharing drivers and applications throughout your organization for a lower total cost of ownership. Plus, with POSIX compliance, switching to QNX is not a big lift. The result can be an efficient and more scalable engineering operation. 

How BlackBerry QNX Can Help

Seven of the top eight medical device manufacturers trust QNX for their patient-critical devices. BlackBerry QNX solutions are used in more than 50 types of medical devices including blood diagnostics, ultrasound imaging, infusion delivery, heart monitoring, resuscitation and robotics for surgery. Learn more about these BlackBerry QNX solutions for your medical device embedded systems:

QNX OS for Safety

Optimize performance and achieve functional safety

Pre-certified to IEC 62304 Class C, QNX OS for Safety is a POSIX-compliant, multicore, real-time OS (RTOS) for building safety-critical devices. It includes qualified C and C++ toolchains, and is supported by feature-rich middleware and professional services. BlackBerry QNX also offers a non-certified version of our embedded operating system.

QNX Hypervisor for Safety

Consolidate multiple systems on a single SoC

Pre-certified to ISO 26262 and IEC 61508 SIL 3, QNX Hypervisor is a real-time Type 1 microkernel hypervisor that provides the trusted reliability and performance of the QNX OS while also allowing multiple operating systems to safely co-exist on the same system-on-chip (SoC). BlackBerry QNX also offers a non-certified version of our hypervisor.

Engineering Services

Bring products to market faster

BlackBerry QNX global engineering services help bring safe, secure and reliable products to market on time, on budget and with quality. With a 40-year proven track record, full-stack expertise and flexible engagement models, we can fit your needs. 

Safety and Security Services

Achieve certifications and improve security

The BlackBerry QNX engineering services team has deep knowledge of safety and security and a near-100% success rate in achieving safety certifications with our customers. With a long legacy in security, BlackBerry has the expertise and solutions you need to secure both systems and supply chains.

Find out how BlackBerry QNX can help you streamline safety certification and accelerate new product introductions.

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Technical Resources

QNX Board Support Packages (BSPs)
QNX Product Certifications for Medical Devices
Deliver Safety-Certified Medical Devices to Market Faster