Software Platform for Medical Devices Comes with Compliance Documentation

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A new software suite 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 Platform for Medical Devices from Wind River 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 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.

Wind River, Alameda, CA. (510) 748-4100. [].