Software Tools Cut A Path To IEC 62304 Compliance

LDRA introduces its tool suite for Medical Devices, a variation of its LDRA tool suite, tailored to help companies achieve IEC 62304 compliance and faster development of safety- and security-critical medical device applications . The LDRA tool suite for Medical Devices automates software quality analysis and testing while providing a traceable, auditable workflow from requirements through deployment for Class II and Class III medical devices.


The embedded software of medical devices now plays a central role in most diagnostic and delivery systems, sharpening the risk for both Class II and life-supporting and life-sustaining Class III devices. The LDRA tool suite for Medical Devices offers a comprehensive set of automated tools for the safe development, deployment, and maintenance of medical device software. This suite of software quality analysis and testing tools delivers bidirectional traceability that connects functional, safety, and security requirements to the objectives of IEC 62304 standard as well as the design, coding, and testing activities and artifacts. By enabling and automating the medical devices’ software development life cycle under IEC 62304, the LDRA tool suite enables developers to create high-assurance software.

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In addition to achieving compliance, the LDRA tool suite improves productivity and efficiency by automating software test activities such as:

  • Software quality analysis
  • Code consistency, understanding, quality
  • Comprehensive testing
  • Change impact analysis


Other features include:

  • IEC 62304 Compliance Management
  • Intrinsic use of and traceability to IEC 62304 objectives
  • Simplified testing and test management
  • Integration with integrated development environments and operating systems in the medical device sector
  • Life Cycle traceability
  • Increased transparency
  • Bi-directional impact analysis
  • Integration with requirements management tools
  • Static Analysis, Software Quality, Safety, and Security
  • Improved software quality by analyzing code for clarity, maintainability, and testability
  • Safer and more secure code through coding standards compliance (MISRA C and C++, HIS, CERT C, CWE, and in-house standards)
  • Data and control coupling analysis
  • Dynamic Coverage Analysis
  • Improved quality of testing through coverage analysis
  • Improved code quality through analysis and visual reporting
  • Increased visibility into the complexities of the application with detailed data and control coupling analysis
  • Dynamic data flow coverage
  • Automated Unit Testing
  • Automated unit, integration, and requirements-based testing
  • Faster and more efficient testing through automatic test harness, test case generation, execution, and results capture
  • Automated support for virtually all target environments
  • Reduced cost of host- and target-based testing
  • Simplified robustness testing
  • Regression testing


LDRA will demonstrate capabilities of its tool suite at ARM TechCon, booth #912, October 24–26, 2017, in Santa Clara, CA. For more information on the LDRA tool suite, please visit LDRA Medical.

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