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LDRA QNX Momentics Integration
Integration of the LDRA tool suite and QNX Momentics Professional Edition

QNX Software Systems Limited, a subsidiary of Research In Motion Limited (“BlackBerry”), is a leading vendor of operating systems, development tools, and professional services for connected embedded systems. Global leaders such as Audi, Cisco, General Electric, Lockheed Martin, and Siemens depend on QNX technology for vehicle infotainment units, network routers, medical devices, industrial automation systems, security and defense systems, and other mission- or life-critical applications. Founded in 1980, QNX Software Systems Limited is headquartered in Ottawa, Canada; its products are distributed in more than 100 countries worldwide. Visit www.qnx.com.

WHITE PAPER: Using Dynamic Software Analysis to Support Medical Device Approval LDRA is the leading provider of automated software testing and analysis tools for the embedded market place. LDRA provides a unique testing platform that helps teams accelerate testing embedded systems and deliver safe and mission critical software on time. Automated Unit Testing, Code Coverage Analysis, Code Review, Quality Review, Design Review and Test Requirement Tracking are key solutions for developers/testers to overcome the challenges of testing embedded software and manage test requirement traceability. The LDRA tool suite supports C/C++, Ada 83/95 and Assemblers.

Two key challenges facing medical device software manufacturer are a) demonstrating safety and b) obtaining approval by regulatory agencies. In this paper we look at how dynamic code analysis can support demonstrations of compliance with safety requirements, and key capabilities to look for in dynamic analysis tools. We conclude with tables mapping development activities with requirements in the IEC 62304 standard, and a short description of important OS characteristics.

Contents

Demonstrating dependability — IEC 62304 — Dynamic analysis — Choosing a software analysis tool — Conclusion — Appendix A: IEC 62304 and development activities — Appendix B: the operating system [–]

Demonstrating dependability

To ensure that their devices receive regulatory agency approvals, manufacturers must demonstrate that the devices meet their safety specifications. For the device software, this means demonstrating that the …

IEC 62304

IEC 62304 is becoming the de facto global standard for medical device software life cycle processes. The FDA has driven its development, and it is being harmonized with EU standard 93/42 EWG (MDD). Like the other standards shown in Figure …

Dynamic analysis

Dynamic analysis is used to examine execution of the compiled source code, either in its entirety or on a piecemeal basis. Since dynamic analysis executes code, it tests not only the source code, but also the compiler, the linker, the development …

Choosing a software analysis tool

All software tool vendors are keen to sell their wares and, understandably, few vendors are particularly keen on advertising what their tools might not do. The following are a list of key points to consider when evaluating a software analysis tool. …

Conclusion

With complex software systems at the heart of so many medical devices, the success of these devices is increasingly dependent on the manufacturer’s ability to demonstrate that these systems meet required levels of dependability. While …

Appendix A: IEC 62304 and development activities

The tables in this section map paragraphs in IEC 62304 with software design, development and validation activities. Adherence to IEC 62304 doesn’t guarantee that the software will meet sufficient dependability requirements or that agency …

Appendix B: the operating system

No matter how good the validation tools, ultimately it is the device and its software that must receive approval. In any system that uses software, everything above the silicon depends on the OS.

Company Overview

QNX Software Systems, a Harman International company (NYSE: HAR), is the industry leader in realtime, embedded OS technology. The component-based architectures of the QNX(r) Neutrino(r) RTOS and QNX(r) Momentics(r) development suite together provide the industry’s most reliable and scalable framework for building innovative, high-performance embedded systems. Global leaders such as Cisco, DaimlerChrysler, General Electric, Lockheed Martin, and Siemens depend on QNX technology for network routers, medical instruments, vehicle telematics units, security and defense systems, industrial robotics, and other mission- or life-critical applications. Founded in 1980, QNX Software Systems is headquartered in Ottawa, Canada, and distributes products in over 100 countries worldwide.