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With the global population growing, the aging of society accelerating, and people becoming increasingly health-conscious, the global medical device industry has experienced rapid growth over an extended period and is expected to maintain steady growth in the foreseeable future. In recent years, with the advancement of computer science and technology, computer software control technology has been increasingly applied in medical devices and has become one of the core technologies in the field. Whether it is high-end large-scale medical equipment such as spiral CT scanners, MRI machines, linear accelerators, or fully automatic biochemical analyzers, or more household-use devices like electronic blood pressure monitors, blood glucose meters, or microwave therapy devices, computer software plays a crucial role in their functionality.

The increasing use of software in medical devices inevitably brings new safety risks. To guide the development, validation, and regulation of software, the IEC has published IEC 62304, “Medical Device Software—Software Life Cycle Processes,” specifically for the medical device industry. Another widely recognized standard internationally is the FDA system in the United States. Both systems classify medical devices into three levels—A, B, and C—based on their risk levels, and these three levels are nearly equivalent across both systems.

To ensure the safety and reliability of medical device products and compliance with IEC 62304 and FDA requirements, it is necessary to establish reliable software development and testing processes. How to efficiently meet IEC 62304 and FDA standards while ensuring system reliability and correctness has become one of the critical issues that medical device software R&D teams cannot afford to overlook.

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Demands and Challenges

  • What specific requirements do IEC 62304 and FDA standards impose on software development processes and testing?

  • How to balance efficiency, quality, and compliance?

  • Code static testing and unit testing are too inefficient.

  • Which stages of black-box testing, gray-box testing, and white-box testing required by IEC 62304 and the FDA can be automated?

  • What automated tools are available to improve software design and testing efficiency?

  • What are the key differences between embedded software and host computer software in terms of testing requirements and methods?

  • Are existing inefficient testing tools easy to upgrade?

  • What are the requirements for certification audits based on IEC 62304 and FDA standards for auxiliary automation development and testing tools?

Solutions

  • Code static analysis, using authoritative static analysis tools such as QAC or Klocwork to meet common coding standards such as MISRA and AutoSAR, and fully comply with IEC 62304 and FDA standards for code static analysis.

  • Unit testing and integration testing, using VectorCAST to verify the reliability and correctness of software unit modules, quickly meeting the requirements of IEC 62304 and FDA for unit testing.

  • Black-box testing, provided by Vector HiL system test platform integrated with “VT System + vTESTstudio + CANoe”, offers physical hardware simulation and system testing solutions for medical device systems.

  • Grey box testing, using DT10 to support embedded software system execution tracking, complex defect tracing, performance testing, etc.

  • Test coverage analysis throughout the software development life cycle (SDLC) to meet the certification audit requirements of IEC 62304 and FDA at all levels.

  • Use Visure Requirements to manage requirements and achieve traceability throughout the software lifecycle in accordance with IEC 62304 and FDA requirements.

  • The commonly used tools provided have been certified and verified by third-party authoritative institutions as complying with IEC 62304 and FDA standards.

Particularly Noteworthy

  • Traceability

  • Code Static Analysis

  • Unit Testing

  • Performance Testing

  • System Testing

  • Traceability

    Using the Visure Requirements Management System, manage the design process at all levels, from high-level product design to high-level design to low-level detailed design, and integrate with commonly used development and testing systems to meet the software requirement traceability requirements of IEC 62304 and FDA standards. More specifically, achieve bidirectional traceability between all stages of the R&D process, including:


    • Between software system requirements and high-level design


    • Between high-level design and detailed design


    • Between software requirements and test cases


    • Between test cases and defects


    This ultimately forms the Requirements Traceability Matrix . The primary purpose of the traceability requirements in IEC 62304 and FDA standards is to ensure consistency and accuracy of information across all stages of the R&D process, as well as efficient change impact analysis, thereby ensuring that the final deliverables do not deviate from the intended objectives.

  • Code Static Analysis

    IEC 62304 and FDA requirements stipulate that the software development process must adhere to a unified coding standard. The QAC code static analysis tool can automatically and authoritatively analyze code compliance, enabling users to quickly and accurately identify non-compliant code, hidden code defects, and structurally unreasonable code, and address common code errors during the initial coding phase. QAC supports common coding standards in the embedded software industry, including MISRA C/C++, AutoSAR C++14, CERT C/C++, CWE C/C++, HiCPP, and JSF, and is compatible with over 30 mainstream development and compilation environments. The QAC tool has been certified by a third-party institution. By using the QAC code static analysis tool, users can quickly meet the code static analysis requirements of IEC 62304 and FDA.

  • Unit Testing

    IEC 62304 and FDA requirements mandate testing of underlying design requirements, which is typically accomplished through unit testing. Verification of the reliability and correctness of individual functions or modules composed of multiple functions can all be categorized under unit testing. Compared to system-level testing of software, unit testing is more cumbersome, time-consuming, and labor-intensive. For embedded software with IEC 62304 and FDA compliance requirements, unit testing is particularly challenging due to difficulties in test-driven development, execution environments, and coverage statistics, making it nearly impossible to perform manually. VectorCAST's embedded software dynamic testing tool offers a specialized automated solution for IEC 62304 and FDA compliance. By leveraging automated test environment creation, automatic test case generation, a graphical test case design platform, flexible management mechanisms, comprehensive coverage statistics, and robust support for over 40 common development environments, it can effectively boost unit testing efficiency by 70-80%. VectorCAST has also been certified by international authoritative institutions and fully complies with the requirements of IEC 62304 and FDA certification.

  • Performance Testing

    Using the DT10 dynamic testing and tracking debugging tool, you can track the execution process of software over a long period of time and measure and analyze the execution performance of various functions, modules, tasks, code blocks, CPU load, and other dimensions in real time. Compared with traditional performance testing using oscilloscopes, the performance testing solution provided by DT10 is more efficient and makes it easier to locate performance anomalies and identify the root cause of problems in the source code.

  • System Testing

    The Vector HiL embedded system network physical simulation and system testing platform, composed of “VT System + vTESTstudio + CANoe,” provides medical device systems with an integrated physical simulation and testing solution that includes test design, test execution, network analysis, I/O interfaces, and stimulus hardware boards. This solution helps users accelerate the establishment of testing environments, testing automation, and automatic regression testing, significantly improving testing efficiency and reducing labor costs. The Vector HiL system testing platform can be integrated with VectorCAST's structural coverage statistics functionality and the Visure requirements management platform to form a one-stop testing and reporting solution.

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