Case Study: EU-based Hemodialysis Treatment Systems Company achieves FDA-ready compliance and 70% unit test coverage with Auriga's automated verification solution

EU-based Hemodialysis Treatment Systems Company - Customer Case Study

EU-based Hemodialysis Treatment Systems Company hired Auriga to verify a new enhanced version of its flagship hemodialysis treatment system. The challenge was to ensure the refactored product met demanding healthcare software and regulatory expectations while covering both embedded and PC-based subsystems.

Auriga implemented automated unit, feature, system, sanity, smoke, and safety testing, along with a custom test framework, HIL-based debugging, and automated scripts for recorded scenarios. As a result, Auriga achieved 70% unit test coverage across about 100,000 SLOC and 1,300 functions on both CPUs, supported IEC 62304 compliance, and delivered documentation and test artifacts needed to pass FDA certification.