Green Hills Software Delivers Enhancements to Industry-Leading Platform for Medical Devices
INTEGRITY-Based Solution Enhanced for Use in Medical Devices Requiring up to Class III FDA Approval
SANTA BARBARA, CA — July 7, 2009 — Green Hills Software, Inc., the world leader in certified safe and secure real-time operating systems (RTOS), today announced major enhancements to its Platform for Medical Devices by adding support for Secure Guest OS Virtualization and expanding the existing networking, file system and target hardware options. The Platform for Medical Devices significantly reduces the cost and risk of Class II and Class III medical product approval while providing faster time-to-market for customers requiring either the premarket notification process, the U.S. Food and Drug Administration’s (FDA) 510(k), or the more stringent Premarket Approval (PMA) process. It also reduces the hardware costs, design complexity, physical footprint and power and heat dissipation of next-generation medical device designs.
”Green Hills Software’s comprehensive Platform for Medical Devices has helped us build our products reliably and efficiently,” said Doug Baker, lead engineer, Carestream Health. “The debugger allows me to connect to a running target and debug it without having to restart and reproduce a problem. This feature is a big time saver and has proven to be of great value during our development process.”
“As the software content and complexity of medical devices continue to increase, the need for a comprehensive approach to safety assurance is required,” commented Mario Morales, vice president semiconductor research, at IDC. “Software that helps developers meet these challenging demands for safety-critical software development tools and a proven process for developing reliable, certifiable software efficiently will offer a clear differentiation in the medical device market.”
The certified safe, secure INTEGRITY® operating system forms the core of the Green Hills Platform for Medical Devices, comprised of integrated development, debug and test tools, operating systems, Secure Guest OS Virtualization, services, and middleware aimed at safety-critical medical devices, such as defibrillators, ventilators, IV infusion pumps, automated heparin analyzers, and infant radiant warmers. This Platform is available for a wide range of target microprocessors-providing customers broad design flexibility.
“Since its initial release in 2005, Green Hills Software has enjoyed overwhelming adoption and success with its Platform for Medical Device development,” commented Dan Mender, vice president business development, Green Hills Software. “With these enhancements, Green Hills continues to deliver the industry’s most mature and flexible solution for customers building life-critical medical devices – all while enabling the shortest time-to-market, highest reliability and lowest development cost.“
The Green Hills Platform for Medical Devices now offers expanded support for:
• Secure Guest OS Virtualization Architecture
• New target processors (TI OMAP3, ARM Cortex A8)
• More reference board support packages
• Wireless supplicant support (WPA/WPA2)
• Partitionable journaling file system (PJFS)
• Enhanced Wear Leveling Flash file system support
• Expanded TCP/IP v4/v6 networking stack, security protocols, and networking applications
• Enhanced USB host stack, device stack and communications class drivers
• Updated life cycle documentation for INTEGRITY
Green Hills Software’s INTEGRITY is the first RTOS that provides guaranteed separation of high risk tasks from low risk tasks running concurrently on a single microprocessor. With this approach, each partition can be analyzed to its appropriate risk level, eliminating the need for separate physical systems or analysis of code beyond the required risk level. In addition, INTEGRITY and its kernel life cycle documentation and release process are tailored specifically for the Class II and Class III medical device market.
About the Green Hills Platform for Medical Devices
Green Hills Software’s INTEGRITY RTOS, the core of the Platform, is a deterministic real-time operating system that carries credentials for reliability, availability, and serviceability, including use in many FDA/CDRH Class II and III-approved life-critical medical devices. The Platform provides a complete software development debug and test solution that helps device makers increase productivity and drastically reduce development cost, per-unit cost, program risk, and product time-to-market. INTEGRITY is fully integrated with a complete range of feature-rich middleware components.
The Green Hills Platform for Medical Devices has been available since 2005 on a wide variety of microprocessor architectures. The new enhancements are available today.
About Green Hills Software
Founded in 1982, Green Hills Software, Inc. is the technology leader in device software optimization (DSO) and real-time operating systems (RTOS) for 32- and 64-bit embedded systems. In 2008, the Green Hills INTEGRITY-178B RTOS was the first and only operating system to be certified by the NSA to EAL6+ High Robustness, the highest level of security ever achieved. Our INTEGRITY® and velOSity™ real-time operating systems, µ-velOSity™ microkernel, compilers, IPv6-ready TCP/IP networking stacks, GateD® Layer 2 switching and Layer 3 routing, MULTI® and AdaMULTI™ integrated development environments, DoubleCheck™ integrated static analyzer and TimeMachine™ tool suite offer a complete development solution that addresses both deeply embedded and high-reliability applications. Green Hills Software is headquartered in Santa Barbara, CA, with European headquarters in the United Kingdom. Visit Green Hills Software at www.ghs.com.