LDRA clears medical device manufacturers’ path to IEC 62304 compliance

LDRA tool suite for medical devices drives high-assurance software development from requirements through deployment

LDRA, the leader in standards compliance, automated software verification, software code analysis, and test tools, announced LDRA tool suite for medical devices, a variant of its leading LDRA tool suite specifically 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 artefacts. 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.”

The LDRA tool suite for Medical Devices will be available Q4 of 2017.