Wind River
Medical
FDA cybersecurity mandates. Safety certification demands. 15+ year device lifecycles. Wind River delivers the platforms medical device maker's trust.
Meeting Medical Device Challenges
New FDA cybersecurity regulations demand SBOMs, CVE monitoring, and vulnerability remediation plans. Meanwhile, many devices must maintain safety certification and support through 15+ year lifecycles.
Medical device manufacturers face a perfect storm: The FDA’s Section 524B and Europe’s Cyber Resilience Act (CRA) require continuous cybersecurity compliance. IEC 62304 demands rigorous safety processes. And devices deployed today must remain secure and supported through 2040 and beyond. Wind River solves all three.
Why Wind River?
Cybersecurity Compliance
Meet FDA Section 524B and Europe’s CRA requirements with automated SBOM generation, continuous CVE scanning, and vulnerability remediation planning.
Learn about Wind River’s Secure Development Lifecycle
Explore moreSafety Certification
Achieve IEC 62304 Class C certification with Wind River’s certified VxWorks RTOS with full evidence documentation that has been used in over 600+ safety certification programs worldwide.
Explore Safety & Certification Services
Explore moreLifecycle Support
Get 15- –years of platform support and maintenance with proactive CVE remediation, keeping devices secure and compliant throughout their operational life.
Explore Lifecycle Services
Explore moreKey Capabilities
Riverfield’s innovative surgical robot
When Riverfield’s innovative surgical robot needed a solution to deliver precision, control, and real-time performance, the company turned to Wind River.