Latest Release of VxWorks Cert Edition IEC 62304 Compliant for Medical Device Development

ALAMEDA, CA – Sept. 25, 2019Wind River®, a leader in delivering software for the intelligent edge, today announced IEC 62304 medical standard compliance for the latest release of VxWorks® Cert Edition. The real-time operating system (RTOS) for safety-critical applications is designed and developed to the highest achievable safety levels accepted by worldwide certification authorities, and now includes a full suite of safety certification evidence across sectors, including automotive, avionics, industrial, and medical.

With this latest certification evidence assessed by auditing body TÜV SÜD, the Wind River RTOS for medical is compliant for use in applications requiring up to IEC 62304 – Class C compliance, a standard for “Medical device software – Software life cycle processes.” The commercial off-the-shelf (COTS) software, along with associated evidence package, is designed for safety-critical medical devices, helping manufacturers reduce or even eliminate the validation efforts around “SOUP” (Software of Unknown Provenance).


“From surgical robots to smart hospitals, new technology is revolutionizing healthcare, bringing new safety and security concerns that must be addressed with stringent industry regulations and standards,” said Amar Parmar, senior director of medical, Wind River. “Developing secure, safety-compliant medical devices requires a balanced blend of regulatory awareness, proven components, and efficiency of design practices; Wind River addresses each of these factors with the latest release of VxWorks Cert Edition.”


This latest medical certification evidence builds on Wind River’s 20-plus years of experience in safety certification software products, and demonstrates the company’s commitment to helping medical technology developers accelerate time-to-market and reduce costs with next generation software solutions.

With its comprehensive software portfolio, Wind River supports a diverse range of medical device manufacturer journeys from design to development to deployment, whether teams require open source and need Linux, or an RTOS, or both. This flexibility allows companies to deliver innovative products that leverage the latest community driven innovations while meeting the safety, security and reliability requirements for mission-critical applications. For more information on Wind River medical solutions visit


About Wind River

Wind River is a global leader in delivering software for the intelligent edge. The company’s technology has been powering the safest, most secure devices in the world since 1981, and is found in more than 2 billion products. Wind River offers a comprehensive portfolio supported by world-class global professional services and support and a broad partner ecosystem. Wind River software and expertise are accelerating digital transformation of critical infrastructure systems that demand the highest levels of safety, security, performance, and reliability. To learn more, visit Wind River at

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