Wind River: VxWorks Cert Edition IEC 62304 now compliant for medical device development
Wind River announced IEC 62304 medical standard compliance for the latest release of VxWorks Cert Edition. The real-time operating system 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).
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.