Software Platform for Medical Devices Complete with Compliance Documentation
Wind River has introduced 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.
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, the industry-leading real-time operating system (RTOS), which has a proven 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. Having VxWorks serve as the core of Wind River Platform for Medical Devices enables the medical device developers to focus on differentiation, while leveraging the core foundational elements of small footprint, determinism, scalability, and high performance.
An essential 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.
Patrick Joda, vice president, global engineering, Varian Medical Systems, commented, “Wind River provides us with the technology platform that we rely on for the mission-critical accuracy required for our TrueBeam system for image-guided cancer treatment. Wind River has helped Varian establish a new level of synchronization between imaging, patient positioning, motion management, beam shaping, and dose delivery technologies. Building upon the reliable performance of Wind River’s VxWorks RTOS, we have created a system that is helping to redefine radiotherapy treatment.”
Wind River offers a broad portfolio of technology solutions that form a complementary solution to Wind River Platform for Medical Devices, including:
“Software has become the key differentiator for medical device manufacturers, and with the Wind River Platform for Medical Devices, along with our comprehensive technology portfolio, we are uniquely qualified to help companies meet relevant safety requirements and standardize on open platforms, while taking advantage of next-generation technologies,” said Santhosh Nair, director of medical solutions at Wind River. “The medical market segment is a significant growth opportunity for Wind River, and already we’re seeing 30 percent year-over-year growth in this segment. Wind River Platform for Medical Devices is the first in a series of related product introductions and enhancements for medical device manufacturers on our roadmap to address this exciting growth.”
More information about Wind River Platform for Medical Devices is available at: http://www.windriver.com/announces/platform-for-medical-devices/.