LDRA clears manufacturers’ path to IEC 62304 compliance

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.

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

• Software quality analysis—Through static and dynamic code analysis, developers ensure that software is safe and secure by construction. Developers gain quick feedback about the testability, maintainability, and clarity of the code.
• Code consistency, understanding, quality—Coding standards, such as CERT, CWE, MISRA, company-defined, or others, are easily tailored and enforced across the team via static analysis.
• Comprehensive testing—Automated test case generation, test harness generation, and test execution greatly shortens and simplifies verification activities. Developers immediately see exactly what has and what has not been tested on the both the host and target platforms using dynamic coverage analysis.
• Change impact analysis—Requirement change impact analysis and regression testing save more time and energy while reducing costs by quickly and easily highlighting the impact of any change within the software development life cycle.

“It doesn’t matter if you’re talking about patient monitors, infusion pumps, defibrillators or imaging systems—many critical embedded systems are rife with safety and security vulnerabilities due to poor programming practices, development language weaknesses, and ineffective software analysis,” said Ian Hennell, Operations Director, LDRA.

“You cannot reduce the risk to the patient or the liability risks of medical device development without creating software that is safe and secure by construction. LDRA helps medical software developers write consistent, maintainable, safe and secure code using proven tools. Companies and patients alike will benefit from reduced risk through the automated analysis and verification of medical software applications.”

Features and Benefits of the LDRA tool suite for Medical Devices:

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

The LDRA tool suite for Medical Devices will be available Q4 of 2017. LDRA will demonstrate capabilities of its tool suite at ARM TechCon, October 24–26, 2017, in Santa Clara, California. Visit the LDRA booth #912 to discuss your requirements.