Software test strategy established for medical device certification

TVS, a manufacturer of software test and hardware verification solutions, has announced that it has established a unit software testing strategy for Creo Medical, a manufacturer of medical devices, thereby highlighting the breadth of its operations and underpinning the trust placed in it by customers working in critical fields.

Creo Medical’s product development team sought advice from TVS on unit testing of the software it was developing for its CROMA system, an electrosurgical unit that delivers bipolar radio frequency power for the purpose of cutting, and microwave power for the purpose of coagulating tissue to staunch bleeding vessels. The CROMA software, which was assessed as safety class C (requiring the highest level of integrity), was to be written in C to run on a 32-bit microcontroller.

TVS assessed the software architecture and design, advised on the content of detailed software design specifications so that unit tests could be developed directly (without the need to view code), set unit test coverage criteria to be met, and devised a host/target based unit test approach.

Craig Gulliford, Creo Medical CEO, commented, “We engaged TVS as they have specialist knowledge of testing safety-related software and had a detailed understanding of the QA Systems Cantata test tool.  They didn’t let us down.  They quickly grasped the software design and provided us with an effective and efficient way forward for software unit testing.  They kept us fully informed of progress at all times and achieved the timescales that we were keen to meet so that we could progress the certification of the CROMA system for human use.”

After developing the unit test strategy TVS provided Creo Medical with a fixed price proposal for undertaking the unit testing. A TVS engineer spent three weeks working closely with Creo’s medical product development team to establish and agree the detailed unit test and management processes before leading the test team. The unit test project proceeded smoothly with any uncovered issues being addressed quickly, and Creo Medical being kept informed of progress with detailed weekly status reports. The completed unit tests were delivered to Creo Medical at the end of the first quarter of 2014, meeting the schedule that had been set.

TVS’ work enabled Creo Medical to proceed with the certification process of the CROMA system software to the medical device software safety standard IEC 62304.

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