Team Consulting speeds medical device certification

Team has begun working with SafeRTOS, an embedded operating system from Wittenstein High Integrity Systems. Accompanied by Wittenstein’s Design Assurance Pack, SafeRTOS enables Team to build systems rapidly while ensuring that the software meets US FDA510(k) Class III and European IEC EN62304 medical device certification requirements.

By using pre-validated and certified software systems Team can more rapidly assemble device management, multi-way communication and safety-critical control systems; complete with advanced, user-centric interactions and graphical user interfaces.

“The knowledge that final approval and certification is a rapid and straightforward process enables designers and clients to work in confidence. Both risks and costs are well controlled” said Chris Ferris, head of electronics and software development at Team Consulting. “SafeRTOS enables us to build robust systems quickly. We can ensure clients hit their targets on the calendar while reducing the risks associated with software validation.”

Team will launch two major product development projects based on SafeRTOS in 2010. This same platform will be offered to all clients as a basis for future development projects.

David Brook, head of marketing at Wittenstein High Integrity Systems said: “The risks associated with using general-purpose software and multiple support organisations are virtually eliminated, thanks to a kernel, certification and support capability that’s delivered through our organisation.“We’re delighted that a market leader, such as Team, has chosen to use SafeRTOS and we expect Team’s experience in the field to contribute to our understanding of the requirements of medical technology development.”