A new software platform for medical devices is part of a comprehensive software portfolio designed for medical device development, including those devices requiring premarket notification, U.S. Food and Drug Administration’s (FDA) 510(k), or the more stringent premarket approval.

The Wind River Platform for Medical Devices is a commercial off-the-shelf (COTS) development and run-time platform enabling safety and security for medical devices. The Platform is built on Wind River’s VxWorks real-time operating system (RTOS), which has a track record for use in regulated medical devices that demand the highest levels of safety, reliability and performance. It also includes Wind River Workbench, a collection of embedded software development tools, as well as critical networking and middleware run-time technologies, such as IPsec, SSL, IPv6 and USB.

An essential component of the Platform is a comprehensive vendor qualification sum- mary (VQS), which includes documented descriptions of the controls and processes Wind River uses to design and develop its platform components. The VQS is prepared in ac- cordance with FDA quality system regulation 21CFR820.50 Purchasing Controls, which require manufacturers to evaluate suppliers for their ability to meet specified requirements, including quality requirements.

Wind River offers a broad portfolio of technology products that form a complemen- tary solution to Wind River Platform for Medical Devices, including:

• Wind River Hypervisor, a high-performance embedded virtualization solution
• Wind River Simics, a full system simulator enabling developers to simulate the func- tional behavior of their target hardware
• Wind River Test Management, a test automation system
• Wind River Tilcon Graphics Suite, a solution for the development and deployment of rich graphical user interfaces for embedded medical devices
• Wind River Workbench On-Chip Debugging, a hardware-assisted debugging solu- tion


Wind River, Alameda, CA.

(510) 748-4100