Solution Briefs and Overviews

Developing Reliable Medical Devices with Confidence

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Clearly, every aspect of the design, development, testing, and deployment of software for a medical device needs to align with the classification factor, and this should be a central focus of development teams. Failure to take the classification requirements into account throughout development and release, as well as in product updates, can cause expensive, time-consuming problems if not addressed as an integral part of the code. Risk management can be an ongoing challenge when trying to launch a medical device cost-effec- tively on a strict timeline, particularly when regula- tory standards must be met. VxWorks Cert Edition includes the integrated security features and IEC 62304–compliant framework that can substantially reduce the risk. As an industry leader in secure, embedded deployments, Wind River continues to modernize its software to cater to the medical industry. PROVIDING MEDICAL-GRADE CREDENTIALS AND A PROVEN REAL-TIME OPERATING SYSTEM Saving time and money in the development and testing of compliant medical devices under IEC 62304 requires an RTOS that satisfies the mandates and has been engineered for hardened deployments in demanding environ- ments, including the aerospace and defense industries. Expertise gained in these areas is carried forward in the latest version of VxWorks Cert Edition and, because it has achieved IEC 62304 compliance, companies develop- ing medical devices can confidently move forward to shorten time-to-market and strengthen the overall security of a solution. As a basic tenet, Wind River designs embedded systems to be secure, safe, reliable, and certifiable. Advances in the technologies that are used in medical devices have transformed practices in this sector, pro- viding more effective diagnosis, monitoring, and treatment of illnesses. This, however, adds complexities to the development and testing of devices. Wind River has been a leader in this area, and VxWorks has success- fully been used in many products from leading firms in the medical sector. Professional services consulting and collaborative support are available for complex projects. With a firm commitment to safety and security, the VxWorks Cert Edition OS stands as a solid foundation for building compliant medical device solutions. From design through deployment, Wind River offers companies the benefit of unrivaled expertise in the technologies needed to succeed in this challenging market. Figure 2. Decision tree for classes as per safety classifica- tion according to IEC 62304:2006+AMD1:2015 Can a hazardous situation arises from a failure of the software? What severity of injury is possible? Class C (by Default) Does failure of the software result in unacceptable risk? No Yes No Evaluate effectiveness of risk control measures external to the software Nonserious Injury Serious Injury/Death Class A Class B Class C WIND RIVER SOLUTION BRIEF Wind River is a global leader in delivering software for the intelligent edge. Its comprehensive portfolio is supported by world-class professional services and support and a broad partner ecosystem. Wind River is accelerating digital transformation of critical infrastructure systems that demand the highest levels of safety, security, and reliability. © 2019 Wind River Systems, Inc. The Wind River logo is a trademark of Wind River Systems, Inc., and Wind River and VxWorks are registered trademarks of Wind River Systems, Inc. Rev. 11/2019

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