Sep 25, 2019 Medical

VxWorks Cert Edition is Now IEC 62304 Compliant

By Davide Ricci

VxWorks has been used in the medical device industry since the early days. The market leading safe, secure and reliable RTOS (real-time operating system) can be found in surgical robots, infusion pumps, dialysis machines, pace maker programmers, assisted ventilators, etc.  When critical Class III devices are being developed, and lives are at stake, medical device manufacturers have turned to Wind River. We will continue to support the industry efforts to innovate reliably and rapidly. To aid in these efforts, we just announced that our VxWorks Cert Edition product has achieved IEC 62304 medical standard compliance.

The IEC 62304 standard is in fact not new. It defines best practices that medical device manufacturers should follow in order to make medical device software safer and more reliable.  Regulatory agencies, such as the FDA (Food and Drug Administration) in North America, or the EMA (European Medicines Agency) in Europe, have enlisted IEC 62304 among the harmonized standards whose compliance with would make it easier to get regulatory approval to sell and operate medical devices.

Why now, then? The answer is to be found in the critical role that software, and in particular the operating system, plays in medical device development. With new regulatory recommendations, the market is being pushed towards accelerating system development and deployment, lowering development costs, while maintaining high levels of safety and security on the device. Using VxWorks as a component in a medical device reduces, or in some cases, even eliminates the manufacturer having to validate the OS using Software of Unknown Provenance (SOUP). This makes the tradeoff between time, cost, quality and regulatory mandates a little bit easier since the OS has been designed and tested with Medical standards in mind.

Speed and time are indeed of the essence here. At Wind River we want to help manufacturers focus on what’s most important for their business – safe, secure and reliable devices. Now they have an RTOS that matches that!

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Online Panel Discussion: Software for Next-Gen Medical Devices

Join us on October 11, 2019, for an online panel discussion debating the regulatory and technical aspects of software for medical devices. Register here >

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