SANTA BARBARA, CA—November 15, 2005—Green Hills Software, Inc., the technology leader in operating systems and software development tools for safe and secure systems, introduced today the Green Hills Platform for Medical Devices, a complete software development and deployment solution for medical devices requiring either the premarket notification process, U.S. Food and Drug Administration’s (FDA) 510(k), or the more stringent Premarket Approval (PMA) process. The Platform for Medical Devices significantly reduces the cost and risk of medical product approval while providing faster time-to-market. It also reduces the hardware costs, physical footprint, power and heat dissipation requirements of medical devices.
The Green Hills Platform for Medical Devices includes:
- the royalty-free INTEGRITY Real-Time Operating System (RTOS), approval-ready for medical devices up to Class III;
- the MULTI development environment, the most powerful and complete set of tools for optimizing the reliability, performance, cost, and time-to-market of device software;
- a full set of life cycle documentation for INTEGRITY, for use in FDA approval of the final device;
- INTEGRITY satisfaction matrix for FDA guidelines and regulations;
- optional middleware, INTEGRITY source code, and quality system audit services; and
- optional Rhapsody environment, a Unified Modeling Language (UML) based Model-Driven Development (MDD) solution for application development from I-Logix, tightly integrated with both INTEGRITY and MULTI.
INTEGRITY is the first RTOS that provides complete support for the guaranteed separation of high risk-low risk tasks running concurrently on a single microprocessor. In addition, INTEGRITY and its associated life cycle documentation will be available for a broad range of target microprocessors.
"The software content of medical devices is growing rapidly as manufacturers seek to increase functionality, improve usability and enhance connectivity," commented Dan O'Dowd, founder and chief executive office of Green Hills Software. "The new Green Hills Platform for Medical Devices enables developers to produce the sophisticated devices that hospitals, doctors and patients want while increasing safety and security and easing regulatory approval."
The Green Hills Platform for Medical Devices delivers a number of significant benefits to developers of medical devices, such as implantable pacemaker pulse generators, automated heparin analyzers, and infant radiant warmers:
- Significantly reduced product approval cost and risk with faster time-to-market. Medical device manufacturers can take advantage of an RTOS that is approval-ready to minimize the quantity of software and documentation that they must develop for product approval. In addition, by utilizing the available Rhapsody Model Driven Development environment, it is possible to link requirements to model elements and to generated code, facilitating the process of proving that all requirements are met. Rhapsody also automatically produces documentation needed to support the approval effort.
- Absolute information security. Strict patient information protection dictated by regulations like HIPPA requires medical devices that collect and distribute patient information to be absolutely tamper proof and secure. The INTEGRITY architecture was designed to prevent hackers’ access to this personal information. And the integrated support for leading networking security protocols and crypto algorithms provides a secure path for untethered transfer of this information to the central hospital systems.
- Reduced hardware costs, power and heat dissipation requirements. Green Hills leading compiler and linker technology allows the end user to develop smaller, faster application code allowing the designer to reduce the memory requirements and processor demands to execute this code. In addition, INTEGRITY’s support for processor-unique power management API’s allow better battery management for hand-held devices
"Model-Driven Development plays a significant role in improving the way medical devices are developed and certified. We have many customers using Rhapsody for this purpose," Neeraj Chandra, Senior Vice President of Marketing and Corporate Development at I-Logix said. "The seamless integration of Rhapsody with the approval-ready INTEGRITY RTOS and expert debugging tools found in MULTI deliver a requirements to deployment development environment required for this market."
About the Green Hills Platform for Medical Devices
The Green Hills Platform for Medical Devices includes:
- INTEGRITY RTOS approval-ready up to Class III
- the MULTI development environment,
- approval assistance documentation, including:
- API usage manual for INTEGRITY
- Extensive INTEGRITY kernel lifecycle data
- Safety-related defect notification service
Additional products and services include:
- “Confidence from Use Assessment” for the MULTI development environment
- INTEGRITY source code
- Middleware components for use in a low-risk partition
- TCP/IP (IPv4 and/or IPv6, with a full complement of security protocols including SSL, SSH and IPsec)
- WiFi End Point and Access Point support with WPA and WPA2 security
- File systems (MS-DOS, wear leveling flash, RAM, M-Systems)
- USB Host stack, device/peripheral support and class driver support
- 2D and 3D graphics
- Rhapsody, Unified Modeling Language (UML) based Model-Driven Development environment for application development
- Services
- End product approval assistance
- Board Support Package (BSP) development and approval assistance
- On-site audit preparation and support
- Quarterly reviews
About Medical Device Approval
There are two main FDA processes for medical device approval. One is the FDA 510(k), which demonstrates that the device is substantially equivalent (SE) to another similar legally marketed device(s). The more stringent Premarket Approval (PMA) requires the device OEM to provide a determination of safety and effectiveness for the device and is meant for devices rated as Class III. A PMA application typically consists of indications for use, device description, results of nonclinical laboratory studies and clinical investigations, and information relating to labeling and manufacturing.
Availability
The Green Hills Platform for Medical Devices will be available in the fourth quarter of 2005 for ARM, Blackfin, ColdFire, MIPS, PowerPC, StrongArm, x86/Pentium and XScale processors.
About Green Hills Software
Founded in 1982, Green Hills Software, Inc. is the technology leader in Real-Time Operating Systems (RTOS) and Device Software Optimization (DSO) for 32- and 64-bit embedded systems. Our royalty-free INTEGRITY® RTOS, velOSity™ microkernel, compilers, MULTI® and AdaMULTI™ Integrated Development Environments and TimeMachine™ debugger 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 on the web at www.ghs.com.
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