Green Hills Platform for Medical Devices

» Download Medical Platform Datasheet (PDF)

   

» Platform overview
» Quality management in safety-critical systems
» Providing safety through partitioning
» Complete range of integrated middleware
» Tools for all stages of system development
» Platform services

 
Platform overview  
  FDA-approved Safety Critical RTOS, DO-178B level A & IEC 61508 SIL3 certification, ISO 9001/90003/12207, Green Hills Software Medical Platform
 
In recent years, medical devices have grown more complex and sophisticated as advances in wireless communication, security protocols, USB, persistent storage, and portable touch screens with graphics have made their way into medical equipment.

With lives dependent on their reliable operation, these devices have strict safety requirements as well as stringent security needs due to the sensitive patient data they store. Software that controls medical devices must go through stringent testing to ensure maximum safety and reliability. As a result, development and deployment of medical device software is usually time-consuming and expensive. Device manufacturers face a daunting challenge: they must balance the integration of new technology without compromising requirements for product safety and reliability and still get their product to market as quickly as possible.

Green Hills Software's Platform for Medical Devices addresses these key issues by providing a complete software development solution that can help you increase productivity and drastically reduce development cost, per-unit cost, program risk, and product time-to-market. At the center of the Platform is Green Hills Software’s INTEGRITY RTOS, which is fully integrated with a complete range of feature-rich middleware components for interaction with other applications and systems in the medical device environment.

The Green Hills solution includes the following tightly integrated components:
  • The INTEGRITY RTOS—a safety-approved off-the-shelf (OTS) real-time operating system (RTOS)
  • Integrated operating system middleware including networking, file systems, USB, embedded databases, graphics and video
  • Integrated design, development and verification tool set for all phases of the software life cycle, including software changes
  • Complete medical device consulting, regulatory assistance, development, audit, and approval services
 
Quality management in safety-critical systems
 
Green Hills development tools, FDA-approved Safety Critical RTOS, DO-178B level A & IEC 61508 SIL3 certification, ISO 9001/90003/12207, Green Hills Software Medical Platform
 
 

The foundation of the Platform for Medical Devices is the royalty-free INTEGRITY® RTOS (INTEGRITY). INTEGRITY has a proven pedigree in safety-critical systems, including deployment in multiple FDA-approved medical devices, multiple DO-178B level A certifications, and IEC 61508 SIL 3 certification.

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.
Providing safety through partitioning
 
 
INTEGRITY software development, FDA-approved Safety Critical RTOS, DO-178B level A & IEC 61508 SIL3 certification, ISO 9001/90003/12207, Green Hills Software Medical Platform
 
 

INTEGRITY is the first RTOS to provide support for medical device applications containing software of multiple Levels of Concern running concurrently on a single microprocessor. Medical device software modules are typically categorized as being of a Major, Moderate, or Minor Level of Concern based on the potential effect that software failures or latent flaws would have on the patient, operator, or bystander.

INTEGRITY allows multiple software applications to share a common hardware platform and enables developers to design applications to prevent an error or failure in one application from negatively impacting the operation of other applications. INTEGRITY achieves this application separation by providing developers with capabilities for complete time, space, and resource partitioning between applications. With this architecture it is possible to divide medical device software into components at various Levels of Concern and be assured that a failure in a Minor Level of Concern component—such as a display or communication stack—cannot cause a failure in a Major Level of Concern component such as a pump controller.

 
  RTOS at Green Hills Software, FDA-approved Safety Critical RTOS, DO-178B level A & IEC 61508 SIL3 certification, ISO 9001/90003/12207, Green Hills Software Medical Platform  
 
Security and privacy
Recent 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.

Scalability
For smaller medical device applications, the velOSity™ RTOS (the core kernel of the INTEGRITY RTOS) runs in flat memory models, minimizing its footprint and optimizing its execution speed. velOSity applications are upward compatible with INTEGRITY, providing a scalable solution if you decide to move to a CPU supporting memory management for the next generation product.
 
 
Complete range of integrated middleware  
INTEGRITY is fully integrated with a complete range of feature-rich middleware components for interaction with other applications and systems in the medical device environment.

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.

  INTEGRITY Middleware, FDA-approved Safety Critical RTOS, DO-178B level A & IEC 61508 SIL3 certification, ISO 9001/90003/12207, Green Hills Software Medical Platform  
 
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).

File systems
The framework model of 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.

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.
 
 
Tools for all stages of system development  
The Green Hills Platform for Medical Devices incorporates best-in-class tools to aid in all stages of the software development life cycle.

  Green Hills MULTI development environment, FDA-approved Safety Critical RTOS, DO-178B level A & IEC 61508 SIL3 certification, ISO 9001/90003/12207, Green Hills Software Medical Platform  
 
MULTI integrated development environment (IDE)
Green Hills Software's MULTI® integrated development environment (MULTI) includes the industry's most powerful and proven tools for developing embedded software with maximum reliability, maximum performance, and minimum code size. With MULTI’s sophisticated, intuitive capabilities, you can develop, debug, and optimize code more quickly, significantly reducing both development cost and time.

MULTI supports more target processors, operating systems, and third-party tools than any other IDE—making it ideal for enterprise-wide deployment. By using a common set of development tools across projects, medical device developers can share code more easily or move between projects without compromising productivity. With MULTI, you can develop code in C, C++, EC++, MISRA C, and Ada 95.

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

Telelogic Rhapsody® SysML/UML modeling and code generation

Telelogic’s Rhapsody Model-driven Development Environment based on UML 2.0 (Unified Modeling Language) and SysML (System Modeling Language) helps software teams move from requirements through system architecture phase with advanced modeling tools. Rhapsody, built upon six proven technologies for higher productivity and higher quality software, is capable of fully modeling system architectures across any discipline and allows the execution, implementation and testing of those models in an easy push button environment. Tightly integrated with MULTI and INTEGRITY, Rhapsody can generate code for INTEGRITY-based systems from the models created with UML. You can also debug Rhapsody models side-by-side with generated source code in MULTI.

Vector Software's VectorCAST™ software test and code coverage
Vector Software's VectorCAST line of products reduce the burden placed on individual medical device developers by automating and standardizing application component level testing—the next generation of intelligent test tools. VectorCAST is a world class integrated software test solution that automates the tasks associated with testing software components for C/C++, Embedded C++, and Ada83/Ada95 programs. Automation includes: complete test harness construction, test generation, test execution, code coverage analysis, regression testing and static measures for code complexity and basis path analysis.
 
 
Platform services  
     
 

The Platform for Medical Devices includes comprehensive services for the medical device industry. In addition to Telelogic and Vector Software, Green Hills has partnered with HighRely, a leading consulting firm in medical device and avionics system development, to provide another layer of advisory, development, and regulatory expertise. The Platform provides the end-to-end services you need to develop highly reliable embedded software for your medical device and meet regulatory agency requirements for device approval.


Medical device product development

  • Project definition and strategic road maps
  • 510(k) jumpstart services and training
  • Requirements definition and transition to software design, development
  • Risk management approaches and assessments
  • Medical device Failure Modes and Effects Analysis (FMEA) and Functional Hazard Analysis (FHA) assessments
  • Independent reviews and evaluation
  • Unit and integration test services
  • Verification services

Tools and RTOS support (MULTI, INTEGRITY, velOSity, Rhapsody, VectorCAST)

  • Tools training
  • Quick start consulting—delivery, installation, and configuration
  • Best practices assessment for use of tools
  • Product customization
  • Custom development
  • Model development
  • Device drivers and Board Support Packages (BSP)
  • Life cycle documentation/process support
  • Supplier quality system audit services (at Green Hills Software headquarters)

 
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