July 16, 2010
Team Consulting speeds medical device certification
New software development approach reduces costs, risk and time to market
July 16, 2010 Cambridge UK: Leading medical technology firm, Team Consulting, is now offering medical device firms new development options that cut both the cost and risk of medical device certification and decrease the time-to-market.
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.”
Ends
Notes to Editors
For more information, please contact:
Team Consulting
Andrew Watts
+44 (0) 1799 532 700
+44 (0) 7776 046 335
andrew.watts@team-consulting.com
www.team-consulting.com
Team Consulting Limited is a leading product development consultancy working primarily in the life science and healthcare industries. Acknowledged experts in medical and drug delivery device development, we work globally with all kinds of companies, from start-up ventures to multinational organisations. Team builds postitive relationships with clients while helping them at all stages of the product development process. We blend design and engineering with creativity and rigour to ensure that our clients get the right product to market at the right time. We are accredited to ISO 9001:2008 and 13485:2003.
About WITTENSTEIN High Integrity Systems
WITTENSTEIN High Integrity Systems is a subsidiary of the German industrial technology group, WITTENSTEIN AG. The group employs over 1500 people worldwide and has a strong track record of technology innovation. WITTENSTEIN High Integrity Systems is based in the UK and develops the OpenRTOSTM and SafeRTOSTM robust embedded kernels for use in industrial, medical and aerospace applications, which require certification. Additional information about High Integrity Systems is accessible at http://www.HighIntegritySystems.com/
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