LDRA, the leader in standards compliance, automated software verification, software code analysis, and test tools, today 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 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. "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," he added.