VectorCAST is the Solution for Complete FDA-Compliant Medical Embedded Application Testing

Ensure Your Medical Device Embedded Software Has Healthy Compliance with Software Quality Requirements

Modern medicine increasingly relies on electronic devices to improve quality of life and medical care. Your devices provide life saving capabilities: patient monitors, infusion pumps, pacemakers, and defibrillators. The common element is all contain significant amounts of embedded software.

These devices need to behave properly and consistently, otherwise the well-being of patients is compromised. Testing is a critical part of ensuring the performance of these devices to pass FDA audits and support the guidelines defined in IEC 62304.

The Complete Solution for Software Testing of Embedded Medical Applications

VectorCAST/C++ allows you to perform unit testing of individual functions or groups of functions to ensure that your application is meeting its requirements, without error. VectorCAST/C++ provides both pass/fail analysis as well as code coverage analysis to support the testing of any class of medical device.

VectorCAST/Cover enables your engineers to assess the thoroughness of system testing by automatically recording which parts of the application are stimulated by each system test. VectorCAST/Cover supports statement, branch and Modified Condition/Decision Coverage (MC/DC) coverage levels. VectorCAST/MCDC coverage was originally developed for the Avionics industry and now many leading medical devices companies have adopted this as a code coverage standard for their FDA Class III or IEC 62304 Class C applications.

 

Proving Due Diligence for FDA Audits

VectorCAST automated testing tools are successfully used by clients demonstrating due diligence with FDA software quality requirements. Whether your device is Class I, II or III, the VectorCAST tools provide a dependable and repeatable testing process for your medical device software development. And the VectorCAST coverage and test case pass/fail reports are exportable to regular HTML or text for easy integration into product documentation delivered to the FDA.

FDA Developer Testing Levels

FDA Developer Testing Levels Satisfied with VectorCAST
Unit (module or component) level testing focuses on the early examination of sub-program functionality and ensures that functionality not visible at the system level is examined by testing. Unit testing ensures that quality software units are furnished for integration into the finished software product.
  • VectorCAST/C++ (unit test)
  • VectorCAST/RSP (target testing)
  • VectorCAST/Manage (regression test)
  • VectorCAST/RGW (requirements tracing)
Integration level testing focuses on the transfer of data and control across a program's internal and external interfaces. External interfaces are those with other software (including operating system software), system hardware, and the users and can be described as communications links.
  • VectorCAST/C++ (unit test)
  • VectorCAST/RSP (target testing)
  • VectorCAST/Manage (regression test)
  • VectorCAST/RGW (requirements tracing)
System level testing demonstrates that all specified functionality exists and that the software product is trustworthy. This testing verifies the as-built program's functionality and performance with respect to the requirements for the software product as exhibited on the specified operating platform(s).
  • VectorCAST/Cover
  • VectorCAST/RGW

According to the FDA General Principles of Software Validation Guidance:

All production and/or quality system software, even if purchased off-the-shelf, should have documented requirements that fully define its intended use, and information against which testing results and other evidence can be compared, to show that the software is validated for its intended use.

Vector Software has developed an extensive software medical device certification kit VectorCAST to meet FDA and IEC 62304:2006 standards.

Further, the FDA document provides a recommended approach to Testing by the Software Developer in section 5.2.5.The various VectorCAST test tools address the software testing referred to in this section and provide an automated capability to satisfy each of the document's requirements.

Section 5.2.5: Testing by the Software Developer

Unit Testing

Software testing entails running software products under known conditions with defined inputs and documented outcomes that can be compared to their predefined expectations.

  • VectorCAST/C++ supports pass/fail analysis of specificed input data and defined expected results for each test case

An essential element of a software test case is the expected result. It is the key detail that permits objective evaluation of the actual test result.

  • With VectorCAST/C++, testers can specify a wide range of valid results for a test including range of values, floating point tolerance, and an exception being raised.

Code-based testing is also known as structural testing or "white-box" testing. It identifies test cases based on knowledge obtained from the source code, detailed design specification, and other development documents. Structural testing is accomplished primarily with unit (module) level testing, but can be extended to other levels of software testing.

  • VectorCAST can support both white box and black box testing


Pass/Fail Metrics

 

Code Coverage Analysis

The level of structural testing can be evaluated using metrics that are designed to show what percentage of the software structure has been evaluated during structural testing. These metrics are typically referred to as "coverage" and are a measure of completeness with respect to test selection criteria. The amount of structural coverage should be commensurate with the level of risk posed by the software.

  • Both VectorCAST/C++ and VectorCAST/Cover provide code coverage metrics. These metrics show you what areas of your code have been exercised and more importantly, what areas of the code have not. It is those areas of code that are not exercised that have increased risk of software failure.


VectorCAST Code Coverage Viewer


VectorCAST Path Coverage Report

 

Regression Testing

Regression analysis and testing are employed to provide assurance a change did not create problems elsewhere in the software product. Regression testing is the rerunning of test cases that a program has previously executed correctly and comparing the current result to the previous result in order to detect unintended effects of a software change. 

  • VectorCAST/Manage allows for full regression testing of all VectorCAST testing at a frequency of your choice, including nightly

Requirements Tracing

Test reports should comply with the requirements of the corresponding test plans.

  • VectorCAST/RGW (Requirements Gateway) enables the mapping of requirements to VectorCAST/C++ unit test cases, and lets users push that mapping information back to their Requirements Traceability tool for full analysis. VectorCAST supports bi-directional data transfer with many requirements analysis tools like DOORS, Requisite Pro, Reqtify, and Polarion, as well as Microsoft Excel and Word.


Requirements to Test Case Mapping

Improving Code Quality While Complying with IEC 62304

Any company that wants to sell a medical device in Europe needs to comply with the IEC 62304 standard.The standard provides a list of tasks and activities that support the safe design and maintenance of medical device software. The goal of this is to ensure the software does what is intended without causing any unacceptable risks. Therefore, IEC 62304 relies heavily on Risk Management strategies.

There are several ways that VectorCAST tools can increase code quality and therefore reduce risk, regardless of whether you developing Class A, B or C medical devices:

VectorCAST/Cover provides standalone code coverage analysis during system testing to identify not only what areas of the application are being executed during system testing but more importantly, which areas are not being executed. Those areas have a higher risk of failure. A typical risk mitigation strategy is to increase the tests being performed on the software to achieve 100% code coverage.

VectorCAST/C++ allows engineers to set up both low level unit tests, which test a single function, as well as higher level software module integration tests, which test a logical grouping of functions. These tests consist of specific inputs to stimulate a function and the expected results indicating successful execution of the code based on the inputs. These tests can be run natively, on a target simulator, or on live target hardware. VectorCAST provides pass/fail analysis to show which expected results were achieved, meaning a passing test case, and which were not, a failing test case. Passing 100% of the tests leads to a higher quality product, and when combined with the code coverage metrics that VectorCAST/C++ also offers, can reduce the risk of failure for code that achieves 100% coverage.

The other area where risk is introduced is when the software changes and the changes are not thoroughly analyzed as to their impact on the overal software application. Regression analysis and testing are employed to provide assurance a change did not create problems elsewhere in the software product. Regression testing is the rerunning of test cases that a program has previously executed correctly and comparing the current result to the previous result in order to detect unintended effects of a software change.  With VectorCAST/Manage, regression testing is automated and can be set up as frequently as you want, including nightly.

 

Commercial Test Tool Validation

Software testing tools are frequently used to ensure consistency, thoroughness, and efficiency in the testing of such software products and to fulfill the requirements of the planned testing activities. These tools may include supporting software built in-house to facilitate unit (module) testing and subsequent integration testing (e.g., drivers and stubs) as well as commercial software testing tools. Such tools should have a degree of quality no less than the software product they are used to develop. Appropriate documentation providing evidence of the validation of these software tools for their intended use should be maintained, known as "Intended Use Validation."

FDA and IEC 62304 Compliance

VectorCAST provides tool validation in the form of qualification documents. The qualification documents consist of Tool Operational Requirements (TOR) and Tool Qualification Data (TQD). TOR describes requirements for VectorCAST tools and TQD, the associated tests and test results. These documents are built for each project and the tests execute on the same compiler/target/runtime environment used by the customer.

The VectorCAST Medical Device Software Compliance Kit for FDA and IEC 62304 includes all necessary documentation for validating embedded software components used on all classes of medical devices.

The kit includes test procedures, plans, coverage and test case reports necessary for Intended Use Validation, and to demonstrate due diligence with FDA and IEC 62304 software quality requirements.

 

With the time savings introduced by VectorCAST, final software development phases could be reached early, reducing the total project costs....Read full story »

Mauricio Ribeiro Barbieri, Software Engineer Manager, AEL Sistemas, A.S.

Vector Software's VectorCAST embedded software testing platform was identified as the ideal solution for developing critical software in compliance with...Read full story »

Dr. Stefan Kaneff, Managing Director, EUROS Embedded Systems

We were impressed with Vector Software from the outset. VectorCAST provided excellent ease of use and functionality.

Read full story »
Chris Brown, Vice President of Engineering, Athena Technologies

Vector Software’s VectorCAST product suite is now more integrated with TI’s Code Composer Studio IDE than ever before, offering users...Read full story »

John Stevenson, Product and Applications Manager, Texas Instruments

Vector Software’s VectorCAST is the leading automated software test tool for safety critical embedded systems, targeting mil/aero, medical and transportation....Read full story »

Dan Mender, Vice President Business Development, Green Hills Software

Trinity is committed to bringing the most innovative and advanced technologies in safety critical software development. We are convinced that...Read full story »

Jeff Chen, Vice President, Trinity Technologies

We evaluated a number of test tools and were impressed with the VectorCAST automated solution. Using VectorCAST/C++, we have significantly...Read full story »

Julieta Catania, Quality Manager, Tecme S.A.

We carefully evaluated a number of tools and we were very impressed with the level of automation provided by the...Read full story »

Steven Lincoln, C-130 Software Development Manager, Lockheed Martin Aeronautics

VectorCAST is the premier dynamic software analysis tool for embedded applications. We are very pleased that our partner, Vector Software,...Read full story »

Mats Ullström, Product Director, IAR Systems

With VectorCAST we are able to quickly apply state of the art unit testing...

Read full story »
Yves Schenker, Embedded Software Engineer, Helbling Technik

Our project requires compliance with DO-178B Level B, which will require stringent testing activities. We needed the best suite of...Read full story »

Vladimir Baburov, Director, VNIIRA-Navigator

We evaluated VectorCAST based on very specific criteria that included the vendors’ experience in safety-critical embedded software testing and the...Read full story »

Michael Dalpiaz, Development Manager, Imaging Systems, Sirona Dental

Overall, we reduced our testing effort 83% by using VectorCAST.

Read full story »
Taeyoung Noh, Quality Assurance Manager NEOS Project, MDS Technology

We are excited to partner with Vector Software in offering developers a powerful, fully integrated solution for embedded systems development....Read full story »

William E. Lamie, President, Express Logic, Inc.

Our test tool evaluation team considered a number of other applications for software testing. We ultimately chose VectorCAST for its...Read full story »

Larry Rogers, Avionics Software Manager, Aurora Flight Sciences

We are very pleased to work with Vector Software. The VectorCAST integration with FreeRTOS provides a engineers with a professional-grade...Read full story »

Richard Barry, Director, Real time Engineers, Ltd.

We are delighted that Vector Software has integrated its industry-leading VectorCAST suite with AdaCore’s GNAT Pro Safety Critical product for...Read full story »

Jamie Ayre, Marketing Director, AdaCore

Our confidence that VectorCAST will provide for our unit test needs is quite high and went beyond expectations.

Read full story »
Ronald L. Martinez, Information Technology, Raytheon Company

Vector Software provides one of a kind capabilities to address the challenges of testing embedded software applications. Representing Vector Software...Read full story »

Uri Farkash, Director of EDA Operations, Advanced Semiconductor Technologies

VectorCAST matches our development paradigm exactly. Therefore the tool was simple to set up and integrate into our development process....Read full story »

Sven Natus, Manager of Software Development, Fujitsu Semiconductor Europe

Big Thanks for this extra-ordinary service!!!

Read full story »
Ronald L. Martinez, Information Technology, Raytheon Company

The open interfaces of VectorCAST give us the necessary flexibility to adapt VectorCAST to all needs in all our development...Read full story »

Sven Natus, Manager of Software Development, Fujitsu Semiconductor Europe

System test alone is ineffective in enabling organizations to achieve customer demanded quality and meet market opportunity windows. To achieve...Read full story »

Axel Kehlenbeck, Sr. Analyst, Sentry Technology Group

With its broad support for target compilers and integrated testing capabilities the VectorCAST applications fit well in our current and...Read full story »

Sven Natus, Manager of Software Development , Fujitsu Semiconductor Europe

VectorCAST is a very important component in our embedded software development process allowing us to detect defects early and assure...Read full story »

Sven Natus, Manager of Software Development, Fujitsu Semiconductor Europe

We evaluated many embedded software testing tools during this process. We chose VectorCAST for its robust features and ease of...Read full story »

Pauline Ng, GM Engineering and Technologies, Flight Focus

The VectorCAST tools have greatly reduced the time it takes to fully test our code. VectorCAST/Manage allows us to...Read full story »

Stanislav Fligl, Core Team Leader, ŠKODA ELECTRIC

I have been using VectorCAST C/C++ on embedded realtime projects for over 3 years. Creating unit tests has been greatly...Read full story »

Alan Yorinks, Software Engineer, ITT Geospatial Systems

Although no hard cost saving metrics were generated comparing the use of VectorCAST/Ada vs. testing with other tools or testing...Read full story »

Mark Hall, Test Consultant, Lockheed Martin

VectorCAST made our job a lot easier.

Read full story »
Taeyoung Noh, Quality Assurance Manager NEOS Project, MDS Technology

The combined offering delivers an unparalleled solution for ensuring quality, reliability, and compliance in the development of critical software systems....Read full story »

Michael Carey, President, Polarion Software

I would like to personally thank David Pierson for his hard work and dedication in helping us here at Northrop...Read full story »

Fernando Anguiano, Senior Staff Software Engineer, Northrop Grumman Aerospace Systems

We are enthusiastic about the integration and partnership with such a high caliber test automation company such as Vector Software....Read full story »

Regg Struyk, Product Manager, Polarion Software

As part of our selection process we evaluated several freeware and commercially available off the shelf applications. We chose VectorCAST...Read full story »

Helen Muth, Senior Director of Engineering, MEI Group

Vector Software engineers were extremely helpful in supporting our goal to achieve DO-178B certification in short amount of time....Read full story »

Pauline Ng, GM Engineering and Technologies, Flight Focus

The decision to use Vector Software's automated solution is driven by our need to achieve the highest levels of software...Read full story »

Fábio Assis, Director, XMobots Robotic Systems

Vector Software’s integration with VxWorks Cert Platform further extends VectorCAST’s support for the comprehensive capabilities of the Wind River Workbench...Read full story »

Joe Wlad, Senior Director of Product Management, Wind River

Automation in testing is typically considered in the context of meeting safety or regulatory requirements. VectorCAST supports our goal of...Read full story »

Arun Devaray, Senior Software Manager, Visteon Electronics

The support we have received from Vector Software has been outstanding. Vector Software’s trainers and support staff consist of highly...Read full story »

Stanislav Fligl, Core Team Leader, ŠKODA ELECTRIC

Vector Software has a proven record of developing the most advanced dynamic software testing solutions that address the real needs...Read full story »

Neil Langmead, Chief Operating Officer, Emenda Software

VectorCAST is unique in that it provides us with the ability to increase the reliability and quality of our flight...Read full story »

Wayne Young, Software Principal Engineer, Honeywell ASCa Inc.

Our leading solutions for Requirements Management, Quality Assurance, and ALM, optimally complement Vector Software’s advanced tools for automated software testing...Read full story »

Michael Carey, President, Polarion Software

Key to our selection of VectorCAST was that it offers a single software engineering platform that can manage process complexity...Read full story »

Stefan Sauerer, MBtech

The VectorCAST testing environment is an ideal complement to the static analysis capabilities available in GNAT Pro, together providing a...Read full story »

Cyrille Comar, Managing Director, AdaCore

The capabilities of VectorCAST for unit/integration test and code coverage perfectly complement our existing static analysis solutions. Coupled with our...Read full story »

Neil Langmead, Chief Operating Officer, Emenda Software

We decided to adhere to all the rules within MISRA and the QA.C tool made this extremely easy to achieve....Read full story »

Lee Jaques, Senior Software Engineer, Marshall Aerospace

Key to our decision was Vector Software's certification of VectorCAST for developing safety related software and its ability to integrate...Read full story »

Don DeLauder, Director, Research and Development, Dräger

The VectorCAST platform provides us with the tools we need to begin development of our newest generation of gas detectors....Read full story »

Don DeLauder, Director, Research and Development, Dräger

See the Benefits of VectorCAST with Your Medical Embedded Software Applications

Discover how VectorCAST code coverage analysis tools improve performance in your exact testing environment by registering today for a 30-day, fully-functional version.

You may also contact us to arrange a demo for your project.