Case Study: Creo Medical achieves IEC 62304-compliant unit testing and 100% MC/DC coverage with QA Systems' Cantata

Creo Medical - Customer Case Study

Creo Medical, a medical device company specializing in minimally invasive surgical tools, required an independently certified automated testing tool to verify the software for its CROMA Advanced Energy Platform under the stringent IEC 62304 Class C standard. The challenge was to rigorously unit test software that controls energy delivery within the human body, achieving full code coverage while managing complex hardware interactions.

QA Systems provided its Cantata unit testing solution, which was successfully deployed on the target environment. The tool enabled Creo Medical to automate testing, achieve 100% Modified Condition/Decision Coverage, and easily simulate hardware for testing on host machines. The results were a streamlined development process, easily maintained tests, and the generation of crucial evidence for regulators. QA Systems' support was also noted as highly effective, and the positive experience has led Creo Medical to plan using Cantata for its next generation of devices.

Creo Medical

Jim Thomas

Software Development Director