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.
The safety classification of IEC 62304 has a tremendous impact on the code development process with requirements outlined from a software development plan and requirements 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.