Test and Verification Solutions establishes software test strategy for medical device certification

PRESS RELEASE

Bristol, UK, 15th July, 2014 – TVS, a leader in software test and hardware verification solutions, today announced that it has established a unit software testing strategy for Creo Medical, a manufacturer of clinically innovative 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.

Further information on TVS’ products and services is available at www.testandverification.com.

About Creo Medical

Creo Medical is a medical device manufacturer based in Chepstow, South Wales.  Founded in 2003, (formerly MicroOncology Ltd) they develop, manufacture and commercialise clinically innovative medical device technologies.  They can draw on over 100 years of employee experience from the medical device sector and are committed to developing clinically relevant technologies.

About QA Systems

QA Systems’ fundamental goals are to accelerate and improve software development. Operating on a global scale, QA Systems has over 350 blue-chip customers, spanning a range of sectors, including aerospace & defence, automotive, medical device and railways. The company supplies and supports its own tools, in addition to carefully selected products from strategic business partners, for static or dynamic testing, requirements engineering, architectural analysis and software metrics.

About TVS

TVS (Test and Verification Solutions Ltd) provides services and products to organisations developing complex products in the microelectronics and embedded systems industries.  Such organisations use TVS to verify their hardware and software products, employ industry best practice and manage peaks in development and testing programmes.  TVS embedded software testing services (asureTEST™) includes onsite/offshore testing support (asureSTAFF™) including assistance with safety certification.  TVS hardware verification services (asureVERIF™) include onsite/offshore verification support and training in advanced verification methodologies.  TVS also offers Verification IPs (asureVIP™) and its own Verification (EDA) signoff tool (asureSIGN™).

TVS Company Contact

Dr. Mike Bartley – TVS
+44 7796 307958
[email protected]

Media Contact

Oliver Davies – Publitek Technolgy PR
+44 1225 470000
[email protected]