Green Hills Platform for Medical Devices

Medical devices have exploded in complexity and sophistication with the integration of wireless communication, security protocols, USB connectivity, persistent storage, and portable touch screens with graphical user interfaces. Moreover, the requirements to construct a system that meets the latest regulatory standards, safely and securely interoperates with other devices, protects patient information, has a reduced footprint, consumes less energy, and costs less to produce all add significant pressure to≠ the device manufacturer.

Platform overview

Platform for Medical Devices reduces development costs and time-to-market

Green Hills Software's Platform for Medical Devices— based on certified technology with an unparalleled proven-in-use history—has enabled Green Hills medical device clients to construct more capable medical devices faster and at a lower cost while addressing the very latest regulatory and technology requirements.

Green Hills Platform for Medical Devices includes:

  • MULTI IDE—The industry's most advanced software development, debugging, and verification tools
  • INTEGRITY RTOS—scalable, full-featured, robust and safety-approved RTOS
  • µ-velOSity™—a small footprint, high performance microkernel for constrained applications
  • Integrated operating system middleware including
    networking, files systems, USB, embedded databases, graphics, and video
  • Domain specific 510(k), PMA support data
  • Industry specific services including consulting,
    regulatory assistance, development, audit and approval support

Proven foundation in safety-critical systems

Green Hills Platform for Medical Devices architecture Green Hills Platform for Medical Devices provides a complete environment for incorporating advances in device design and development while still maintaining the high levels of safety and security that medical devices require.

Green Hills Software operating system technology is the proven foundation for safety-critical application development and deployment. This operating system technology has been deployed and proven in use to be safe and effective in numerous Class II and Class III medical devices deployed throughout the world.
At the heart of the Platform for Medical Devices is Green Hills INTEGRITY real-time operating system (RTOS) and the high performance, small footprint µ-velOSity microkernel. INTEGRITY offers a robust separation kernel platform for full-featured applications running on microprocessors with memory management and the potential for multiple methods of device connectivity and interoperability.

µ-velOSity is ideal for power and size-constrained applications requiring a reduced feature set, in environments with a low per unit cost and no memory management. Both operating system technologies are fully integrated with a range of feature-rich middleware components. This choice of operating system technology lets you select the appropriate level of functionality, capability, performance, and size for the application.

The INTEGRITY RTOS has a proven pedigree in safety-critical systems. Outside of the medical device market, INTEGRITY technology has been at the heart of numerous safety-critical aerospace, defense, industrial, and transportation applications.

The Platform for Medical Devices' INTEGRITY kernel goes through a stringent software engineering development life cycle based on ISO 9001/90003/12207 quality management processes and procedures. The resulting documentation and records support the medical device developer's product approval activities. INTEGRITY is approval-ready for deployment in Class II and III medical devices with all supporting life cycle documentation.

INTEGRITY: Providing safety, security, and reliability through partitioning
INTEGRITY is the first RTOS to provide support for medical device applications containing software of varying safety classifications such as those identified under IEC 62304. In this international standard describing the life cycle processes for medical device software, Class A, Class B, or Class C describes the escalating safety-classification corresponding to the increased risk of serious injury or death to the patient or others. Under this standard the failure of a software item designated with Class C safety-classification could potentially result in death or serious injury. A good design practice would separate applications with different levels of concern to ensure that no one application could adversely affect another. With INTEGRITY, it is possible to cleanly separate critical from non-critical tasks using resource partitioning in both time and space, mitigating potential risks in safety- and life-critical systems.

Security and privacy

INTEGRITY RTOS partitioned  architecture With the INTEGRITY RTOS, developers can design applications that prevent an error or failure in one application from negatively impacting the operation of other applications.

HIPAA laws have extended the security and privacy requirements for medical device manufacturers well beyond the traditional safety requirements. Medical devices now need layers of security software to ensure that sensitive patient data stored on or transmitted from the device is kept private. The partitioning capabilities of the INTEGRITY RTOS provide an excellent framework for building secure software.

For the protection of transmitted data in wireless applications, Green Hills has partnered with wireless security providers supporting WPA and WPA2 standards. In addition, Green Hills supports the latest in internet addressing and security protection mechanisms such as IPv4/IPv6, IPsec, SSL, SSH, and RADIUS. Green Hills Software also offers a cryptographic toolkit that is FIPS-validated.

Range of integrated middleware

INTEGRITY RTOS Middleware The INTEGRITY RTOS is fully integrated with a complete range of feature-rich middleware components.

INTEGRITY and µ-velOSity are fully integrated with a range of feature-rich middleware components for interaction with other applications and systems in the medical device environment. Each operating system offers a scalable middleware architecture with INTEGRITY providing a more feature-rich middleware environment off-the-shelf.

Networking support
A complete suite of integrated networking and communications products is provided with INTEGRITY, including a variety of wired and wireless communications protocols, as well as the latest security protocols. These protocol stacks and security components can be placed in secure software partitions with stack access given to only entitled applications.

USB
High-performance USB solutions provide both host and device (function) support and include numerous class drivers and example applications (source code provided for stacks and drivers).

Graphics and video support
INTEGRITY offers extensive support for embedded graphics development spanning from deeply embeddable 2D graphics to the advanced 3D graphics environment via OpenGL.

File systems
The framework model of the INTEGRITY's file system—commonly referred to as a virtual file system (VFS) framework—makes it easy to add and remove support for various file systems. The VFS server provides file system support for UNIX-like file systems, DOS/FAT 12/16/32, ISO 9660, Wear Leveling Flash File Systems, and others.

Embedded databases
INTEGRITY has integrations with several leading embedded databases to fit a variety of application needs. The database solutions for INTEGRITY range from those with extremely small footprints, to distributed databases with real time updates, to full blown SQL-compliant databases.

Tools for all stages of system development

MULTI integrated development environment (IDE)
Green Hills Software's MULTI® IDE includes the industry's most powerful and proven tools for developing embedded software with maximum reliability, maximum performance, and minimum code size. With the MULTI's sophisticated, intuitive capabilities, you can develop, debug, and optimize code more quickly, significantly reducing both development cost and time.

Green Hills Software's TimeMachine™ Suite extends MULTI's capabilities by enabling visual analysis of execution to improve application reliability and reduce development time. Medical device developers can use these tools for code coverage testing, forward and backward debugging and performance profiling.

Green Hills Software's DoubleCheck™ Integrated Static Analyzer provides built-in static code analysis that is tightly integrated with the compiler technology, ensuring that the same code analyzed is the same code deployed, mitigating risk in the safety-critical development life cycle.

IBM® Rational® Rhapsody® SysML/UML modeling and code generation
IBM Rational Rhapsody family provides a visual development environment based on industry standard UML (Unified Modeling Language) and SysML (System Modeling Language) that helps systems engineering and software teams move from requirements through system architecture phase, design, implementation and test in an automated and cohesive fashion using execution for early validation of requirements. Rational Rhapsody is capable of fully modeling system architectures across multi-disciplines and supports the execution, implementation and testing of those designs in an easy push button environment. Tightly integrated with MULTI and INTEGRITY, Rational Rhapsody can generate code for INTEGRITY-based systems from the models created with UML. You can also debug Rational Rhapsody models side-by-side with generated source code in MULTI.

Vector Software's VectorCAST™ software test and code coverage
VectorCAST™ is an automated embedded software test solution used to satisfy the FDA and IEC 62304 compliance requirements.The VectorCAST solution reduces the burden placed on medical device application developers by automating and standardizing unit and integration level testing. Automation includes: complete test harness construction, test generation, test execution on target or simulator, code coverage analysis, regression testing, and static measures for code complexity and basis path analysis.

Platform services

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