LDRA Speeds Medical Device Design with IEC 62304 Compliance

Medical devices have become increasingly sophisticated, employing software-controlled applications whose failure to function correctly could result in death or serious injury. Despite this increased complexity, medical software standards have continued to reflect only the rigor of software quality typical of applications with low levels of risk. IEC 62304 introduces a risk-based compliance structure—Class A through C where the failure of Class C software could result in death or serious injury—that ensures that medical applications must comply with the standards suitable for their risk assessment.

“As the US and international governments raise the stakes for company CEOs to make sure their products operate safely, it is incumbent on them to use best practices in the design and development of those products,” noted Ian Hennell, LDRA Operations Director. “LDRA’s ability to prove compliance to the IEC 62304 standard and to integrate that compliance into all stages of development from requirements to verification provides the confidence medical companies need that their devices will withstand scrutiny and help them defend against any product liability claims they may encounter.”

The safety classification of IEC 62304 has a tremendous impact on the code development process with requirements outlined from a software development plan through verification, integration and system test. While in practice all companies developing medical device software will carry out some level of due diligence on all software classes, the higher risk Class B and C code requires more formal detailed documentation along with cross-referencing and verification of requirements. By integrating compliance to IEC 62304 into its entire tool chain, LDRA ensures that medical device developers can automatically trace requirements from design through system test and verification, saving a great deal of time and money in software development.

“The LDRA tool suite has been invaluable in developing our implantable technology for treatment of high blood pressure and heart failure,” noted Ryan Smith, Senior Principal Firmware Engineer at CVRx, Inc. “We needed a scalable solution that complemented our in-house testing and could be configured for custom hardware targets and multiple compilers. The LDRA tool suite has repeatedly delivered, providing multiple strategies to drive early defect detection as well as promoting long term quality assurance through daily execution of regression test suites.”

“The requirement for due diligence has put the onus on the medical device manufacturer to ensure medical software has been rigorously tested and complies with specified device standards,” confirmed Hennell. “With more than 35 years’ experience verifying safety-critical software, we have developed tools that automate the testing and verification process, ensuring greater reliability, fewer program errors, and reduced development time and resources. We welcome the opportunity to assist medical device companies such as CVRx to implement software standards throughout their software development lifecycle to ensure compliance with IEC 62304.”