Team Consulting, a product development consultancy working primarily in the life science and healthcare industries, is offering new development options for medical device firms to reduce both the cost and risk of medical device certification and decrease the time-to-market.
Team Consulting has begun working with SafeRTOS, an embedded operating system from Wittenstein High Integrity Systems.
Accompanied by Wittenstein’s Design Assurance Pack, SafeRTOS enables Team Consulting to build systems rapidly while ensuring that the software meets FDA510(k) Class III and European IEC EN62304 medical device certification requirements.
By using pre-validated and certified software systems, Team Consulting can more rapidly assemble device management, multi-way communication and safety-critical control systems, complete with advanced, user-centric interactions and graphical user interfaces.
Team Consulting also expects to launch two product development projects based on SafeRTOS in 2010. The same platform will be offered to all clients as a basis for future development projects.
Chris Ferris, head of electronics and software development at Team Consulting, said: “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.
“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.”
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.”