OverviewAs populations age and health care costs come under ever more scrutiny, innovations in medical device design can be a defining differentiator in the marketplace. For over 30 years, the QNX® Neutrino® RTOS has been providing a full-featured, multi-core operating system that exceeds the most demanding requirements for reliability, performance, data safety, and security. With QNX's field-proven portfolio of pre-integrated technologies, solutions, certification services and a broad partner ecosystem, developers can focus on application design and functionality.
QNX Software Systems has significant presence in the healthcare industry with a platform that enables highly reliable, available, connected, and secure medical devices, including:
- Blood analyzers to test blood samples
- Pulse oximeters to measure the oxygen saturation of a patient's blood
- Handheld CTG monitoring units to monitor babies' heart rates
- Angiography to visualize blood vessels
- Diagnostic equipment
- Patient monitoring units to monitor vital signs
- Anaesthesia monitoring devices
- CardioQ hemodynamic monitoring systems to evaluate heart performance
- Hemodynamic cardiac/pulse monitors
- Retinal scanning devices
- High performance lasers for eye surgery
- Electrocardiograph stress test equipment
IEC 62304-compliant operating system
A realtime operating system can be a critical component of a safety-critical device, providing inherent security, reliability, and high availability. The QNX® Neutrino® RTOS microkernel architecture incorporates core functionality into a tiny, well-tested kernel while leaving drivers, networking stacks, and other OS services outside in memory protected space – providing a high degree of determinism and fault-tolerance. Choosing the right RTOS partner can simplify certification processes, can provide clear product differentiation and help to realize significant bill of materials (BOM) and cost advantages.
Further reductions in costs and efforts can be achieved in a project by leveraging the QNX® OS for Medical that is declared compliant to IEC 62304. The burden of compliance is lifted from the medical device manufacturer and proof is provided directly from QNX through certificates of conformance and extra support documentation. Documents such as Hazard and Risk Analysis, User Responsibility Guide, and Technical Safety Case documents are available to ease the burden of proof for the operating system component of the medical device.
To address the ever-increasing security threats facing embedded systems, whether they are large distributed systems or small isolated industrial controllers, QNX has advanced security mechanisms that are built directly into the QNX Neutrino RTOS that protect devices from malicious attacks. These can be used to ensure that all processes, including drivers and filesystems, execute in user-mode, greatly reducing the ability of compromised processes. Further, it is possible to divide the filesystem into encrypted domains, as well as to randomize the address space layout for further protection against malicious intent.
The security attack surface of the system can be further reduced by utilizing a unique ability to control settings that govern and protect which operations a process can perform, with granularity down to the system-call level. As a result, embedded developers no longer have to give processes root permissions and access to the entire system in order to gain access to necessary system resources.
Integrated development environment
The QNX® Momentics® Tool Suite is an Eclipse-based IDE that is tightly integrated with many sophisticated tools for debugging and optimizing code during different phases of the software development cycle. Innovative profiling tools provide insight into system and application behavior - facilitating code coverage testing, performance profiling, debugging, and source-level verification. Reusable software assets and industry standard tools allow for system scalability and portability both in the short-term and down the road.
Graphics / Human-machine interfaces (HMI)
The QNX Neutrino RTOS provides a level of graphics and mobile techniques offered by no other commercial RTOS.
QNX delivers a compositing windowing system which integrates multiple graphics and user interface technologies into a single scene. This scene is then rendered into one image that is associated with a display. This allows the designer to use the most appropriate graphics technology that corresponds with the image, be it video, OpenGL® ES, HTML5, or Qt 5.
With the QNX Neutrino RTOS, developers can build graphically-rich, compelling user interfaces (UIs) using built-in, high performance OpenGL ES-based transitions. They can also support multi-touch displays and gestures, and render images from Qt, HTML5, video, and other technologies through a single compositing windowing system, which integrates multiple graphics and UI technologies into a single scene.
The screen subsystem of the QNX Neutrino RTOS is responsible for:
- Running all drivers (input, display, OpenGL ES)
- Allocating memory needed by application windows
- Displaying content when rendering completes
Screen integrates multiple graphics and user interface (UI) technologies into a single scene. This scene is rendered into one image that is associated with a display.
Multi-touch input control
QNX supports the multi-touch graphical displays that are in wide use. The Input Events library has been extended to support multi-touch screens. The Gestures library provides gesture recognizers to detect gestures through touch events that occur when you place one or more fingers on a touch screen.
The video capture framework enables applications to capture frames from a video input source and display them using the Screen compositing windowing system.
Media capabilities are becoming increasingly important in industrial applications, especially in systems that provide a rich user experience. QNX Software Systems has support for a wide range of middleware technologies (including audio and video codecs) and data streaming for applications, such as network security cameras.
The QNX® SDK for Apps & Media offers a fully customizable, full-featured multimedia framework for quickly building high value, media-rich solutions that range from simple media players to multi-source, multi-mode devices with seamless mobile device connectivity. Device implementations include:
- Industrial control systems
- Transport media systems such as automobile, aircraft, and trains
- In-seat entertainment systems
- Medical device imaging and sound monitoring units
- Marine and heavy machinery head units
- Consumer white goods displays
Optimized HTML5 engine and web browser
The HTML5 engine is the foundation for HTML5-based user interfaces. It is based on the WebKit open source web browser engine, which QNX has optimzed for embedded environments, and to which QNX has added numerous capabilities to provide a full-featured web browser to offer the fastest HTML5 rendering performance and broadest support for HTML5 standards.
QNX Software Systems supports a wide range of block and flash filesystem formats along with a power-safe disk file system for guaranteed data integrity and reliable storage. The flash filesystem (FFS3), designed primarily for NOR flash, supports wear-leveling, error-handling, background reclaim, and fault recovery. The NAND flash file system (ETFS) offers wear-levelling and resists power failure corruption.
High availability is not optional for life-critical medical devices. The QNX framework provides critical process monitoring and restarts without the need to reboot, ensuring 100% device uptime.
Adaptive partitioning offers dynamic scheduling capabilities to enforce guaranteed service availability as well as optimize device performance. This is particularly important when integrating third party software – which is often CPU intensive. By eliminating wasted, unused cycles created by fixed partitioning designs, adaptive partitioning speeds time to market and does away with the complex task-starvation problems that typically arise during integration.
QNX Software Systems offers one of the most comprehensive networking solutions for an embeddable RTOS with capabilities typically reserved for desktops and servers. The native distributed processing supports complex distributed systems in which multiple devices seamlessly share resources and communicate without custom protocols. The networking ecosystem offers support for all forms of wireless networking from point-to-point connections such as Bluetooth and ZigBee, to peer-to-peer networking like WiFi (802.11) – without compromising safety or security of sensitive patient data.
As outlined in the Health Insurance Portability Accountability Act (HIPAA) in the United States, patient data must be stored and transmitted in ways that maintain strict data privacy measures. QNX provides support for a number of authentication and security protocols including: WEP, WPA/WPA2, Radius, 802.1x, SSL, IPSec, IPv6, and NAT.
Safety, security, reliability, and quality are essential for any medical device. All these values reside at the very core of the QNX software architecture. They also form the foundation for certifications critical to all medical devices. To demonstrate its commitment to the medical devices market, QNX Software Systems has undertaken several strategic certification programs to help customers concentrate on innovating, reducing costs, speeding time to market, and improving the quality of their software assets.
The QNX management system is certified to the internationally recognized ISO 9001:2008 standard. ISO is firmly established as the globally implemented standard for providing assurance about the ability to satisfy customer requirements and enhance satisfaction. Auditors have evaluated and then certified the processes and systems governing the design and development of QNX software, as well as the provision of related support services.
ISO is the world's leading developer of voluntary, consensus-based international standards. There are more than 16,500 current ISO standards and related documents that specify the requirements for state-of-the-art products, services, processes, materials and systems, and for good conformity assessment, managerial and organizational practice.
IEC 62304 Software Life-Cycle for Medical Devices
The QNX® OS for Medical is compliant with the requirements of International Electrotechnical Commission (IEC) standard 62304 Software Life-Cycle for Medical Devices. IEC 62304 is an international standard that provides a framework of life cycle processes with activities and tasks, and incorporates risk management requirements as outlined in IEC 14971.
IEC 61508 Safety Integrity Level 3 (SIL 3)
The QNX® OS for Safety is certified to meet the requirements of International Electrotechnical Commission (IEC) standard 61508 Safety Integrity Level 3 (SIL3). IEC 61508 is an international standard for the functional safety of electronic systems, and offers a very high level of reliability and risk reduction when used in safety-critical systems for transportation, energy generation, process control, and other industries. Meeting the IEC 61508 requirements involves a systematic assessment by an independent certification body.
Common Criteria ISO/IEC 15408 Evaluation Assurance Level (EAL) 4+
The QNX® OS for Security is certified to meet the stringent requirements of the Common Criteria ISO/IEC 15408 Evaluation Assurance Level (EAL) 4+. The Target of Evaluation (TOE) includes not only the mature QNX OS kernel, but also its multi-core (symmetric and bound multiprocessing) and secure partitioning technology. Certification to EAL 4+ validates that the security parameters claimed have been methodically tested by an independent lab and the certification authority (the Canadian Security Establishment (CSE)), and means that the QNX OS for Security will exceed the assurance requirements required for EAL4.
The Common Criteria for Information Technology Security Evaluation is an international standard agreed to by the United States Government, Canada, and 23 other nations. It establishes standards for security functionality, security assurance, and security evaluation.
POSIX PSE52 Realtime Controller 1003.13-2003
The QNX® Neutrino® RTOS has been certified for conformance to the POSIX PSE52 Realtime Controller 1003.13-2003 System product standard, under the “POSIX: Certified by the IEEE and The Open Group” program. As a result, commercial customers and government agencies can choose the QNX Neutrino RTOS with the assurance that it provides both the code portability and the realtime determinism needed for an array of military, networking, medical, and automotive systems. In addition to the functions covered in the PSE52 standard, the QNX Neutrino RTOS supports many hundreds of other POSIX 1003.1 commands, utilities, and programming interfaces.
POSIX PSE52 certification also confirms QNX Software Systems’ commitment to the software defined radio (SDR) market, including the U.S. military’s Joint Tactical Radio System Software (JTRS) SDR program. PSE52 serves as a cornerstone of the Software Communications Architecture (SCA), the interoperability standard mandated by JTRS.
QNX Software Systems is certified conformant to the OpenGL® ES standard. OpenGL ES is a cross-platform API for full-function 2D and 3D graphics on embedded systems. QNX is also a contributing member of the Khronos Group, the industry consortium focused on the creation of open standard APIs to enable the authoring and playback of dynamic media on a wide variety of platforms and devices. QNX is active in the OpenGL ES and OpenVG™ projects, which help bring accelerated 2D and 3D graphics to in-car computing devices, casino gaming applications, industrial control systems, and a variety of other embedded platforms.
With QNX, industrial customers have the assurance of using a software architecture proven in thousands of mission-critical and life-critical environments, including medical devices. In fact, QNX Software Systems has passed all audits by medical device companies seeking FDA approval for their QNX technology-based products.
QNX Software Systems recognizes the importance of delivering pre-integrated solutions to meet the growing challenges faced by medical device customers — regulatory burdens and unrealistic schedules, for example. As a result, the QNX partner ecosystem includes a wide range of processors, protocols (connectivity, security, and networking), tools, and package solutions for building almost any reliable and safety-critical medical device.
QNX Professional Services provides the end-to-end services medical device manufacturers need to develop highly reliable embedded software and meet regulatory agency requirements. Our services range from architectural reviews through software debugging, and optimization to support for building rich human-machine interfaces.
IEC 62304 compliance assistance
QNX Professional Services can help pave the path to compliance. By leveraging existing data on various QNX-supported hardware platforms and QNX expertise in IEC 62304 compliance, the Professional Services team can identify the best solutions to shorten time to compliance and considerably reduce costs at the system level.
Graphic / human-machine interface consulting services
The need for a rich and compelling user experience is not an optional feature for many medical devices. The challenge for device vendors is to train their development teams to produce cutting-edge human-machine interface (HMI) solutions. The QNX Professional Services team has many years of experience designing, developing, and optimizing HMIs for various target platforms from a mix of technologies — Flash, HTML5, and native apps (OpenGL® ES and OpenVG™). This experience includes training engineering teams and building prototypes.
QNX® OS for Security extension service
As remote access and connectivity become increasingly popular in medical devices, the challenge for device manufacturers is to keep transient patient electronic data secure. This however is becoming increasingly complex due to HIPAA regulatory requirements and the Common Criteria ISO/IEC 15408 EAL4+ certification, which is proving to be the standard of choice for security requirements. The QNX® Neutrino® RTOS is certified to the stringent security requirements of the ISO/IEC 15408 EAL4+, which includes two hardware platforms (x86 with SMP and ARMLE). Recognizing the diversity of QNX's customer base, there are a range of services to help obtain the same certification on other versions of the QNX Neutrino RTOS, to expand the scope of certification to include modules that are critical to success, and to incorporate new hardware platforms in medical device certifications.
FDA consulting service
QNX Software Systems has a proven track record of successfully helping companies with FDA approvals for devices running the QNX Neutrino RTOS, including FDA 510(k) clearance.The QNX Professional Services team can also provide product life cycle management services — everything from process reviews to quality system audits. QNX also offers pre-qualified partners in a broad medical ecosystem to provide pre-market notification services as well as the more complex pre-market approval (PMA) process.