Wind River is the next major operating system (OS) vendor to understand the value of having an enriched medical offering. The company recently introduced a platform for medical devices, which is part of a comprehensive software portfolio designed for medical device development, including those devices requiring premarket notification, FDA 510(k), or the more stringent Premarket Approval.
The offering is a commercial off-the-shelf (COTS) development and run-time platform enabling safety and security for medical devices. It’s built on the company’s VxWorks real-time OS and includes 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. With the platform, 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.