Green Hills Platform for Medical Devices

As medical devices have exploded in complexity and sophistication, a myriad of other requirements—meeting the latest regulatory standards, safely and securely interpolating with other devices, protecting patient information, reducing footprint, energy requirements, and production costs—all add significant pressure to the device manufacturer.

Platform overview

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

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 Platform for Medical Devices— based on certified technology with an unparalleled proven-in-use history—enables developers to design medical devices faster and at lower cost while addressing the latest regulatory and feature requirements.

Green Hills Platform for Medical Devices includes:

  • MULTI IDE— leading software development, debugging, and verification tools
  • INTEGRITY RTOS—scalable, full-featured, robust and safety-approved RTOS
  • µ-velOSity RTOS—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

Proven 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 systems and the high performance, small footprint µ-velOSity RTOS. 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 Platform for Medical Devices’ INTEGRITY kernel goes through a stringent software engineering development life cycle based on rigorous 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.

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.

Range of integrated middleware

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. MULTI includes the TimeMachine debugging suite, which enables visual analysis of execution to improve application reliability and reduce development time, as well as the DoubleCheck integrated static analyzer, which provides built-in static code analysis 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.

LDRA software quality and test tools
The LDRA tool suite is the most complete software verification and validation solution for the development of medical device software. These tools support the FDA and other medical device regulatory body guidelines from device development through device clearance and audit support. LDRA’s software testing tools expedite your certification/approval process through:

  • Tracing all requirements, design, and verification artifacts throughout the software development life-cycle
  • Complying with coding standards (industry- and user-defined)
  • Automating unit test and system-level test
  • Performing and reporting coverage analysis on all code down to the target level
  • Planning for and executing requirements-based testing
  • Green Hills MULTI and INTEGRITY integration
  • TÜV certified enabling IEC 62304 Compliance

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.

Platforms you can trust

The networked manufacturing floor is just as susceptible to cyber security attacks as the networked office. To ensure medical devices are secure from the very start, INTEGRITY Security Services (ISS, A Green Hills Software company) offers Device Lifecycle Management (DLM), a high-assurance key management infrastructure. With DLM, medical device manufacturers can manage digital trust assets and cryptographic operations across global manufacturing supply chains.

Backed by FIPS 140-2 Level 3 assurance, DLM securely generates, distributes, and injects keys, certificates, and sensitive data to provide zero exposure encryption of all devices across untrusted manufacturing sites. With DLM, digital assets are protected until individually metered into each device, preventing compromise at all locations.

ISS also offers Cryptographic Toolkits to protect medical devices from cyber security attacks once they’ve been deployed. With this suite of approved algorithms and protocols, developers can:

  • encrypt data in transit and storage
  • authenticate remote commands and data
  • verify software is not tampered with before executing

Fundamental to repelling cyber attacks is secure boot. Starting with an immutable root-of-trust, software is authenticated, layer by layer prior to execution. With the ISS Secure Boot Tookit, medical device developers can tailor boot authentication to specific requirements and deploy the most optimal configuration.

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