Wind River has launched Wind River Platform for Medical Devices, 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 new platform is a commercial off-the-shelf (COTS) development and run-time platform enabling safety and security for medical devices. It is built on Wind River’s VxWorks real-time operating system (RTOS). 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.
A component of the Platform is a comprehensive vendor qualification summary (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 accordance 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 Platform for Medical Devices is the first in a series of related product introductions and enhancements for medical device manufacturers on the company's roadmap.
More information about Wind River Platform for Medical Devices is available at the company's platform for medical devices page.
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