Case Study: Creo Medical achieves IEC 62304 Class C compliance with QA Systems’ Cantata

Creo Medical achieves 100% MC/DC with QA Systems

Creo Medical, a medical device company, required an independently certified automated unit testing tool to verify the software for its CROMA Advanced Energy Platform, a Class IIb surgical device. Their challenge was to achieve compliance with the stringent IEC 62304 standard while managing frequent software changes through their agile development process. They selected the Cantata testing tool from vendor QA Systems based on a consultant's recommendation and its certification for this high-integrity class of software.

QA Systems implemented its Cantata tool, which allowed Creo Medical to automatically unit test software units in isolation by using features like memory-mapped hardware registers and stubs for external functions. The solution enabled them to achieve 100% Modified Condition/Decision Coverage (MC/DC) as required for certification and to easily maintain and refactor tests. The results included a streamlined development process with automated regression testing and the generation of easily reviewable evidence for regulators, making Cantata an integral part of their workflow for the existing device and future projects.

Creo Medical