Automating IEC 62304–Compliant Unit Testing for the hinotori Surgical Robot
From change-based regression testing and code coverage reporting to CI-ready workflows with VectorCAST
The Japanese surgical robot hinotori stands for high-precision, minimally invasive surgery – and for extremely demanding software development. In this technical article, you’ll discover how Medicaroid and Kawasaki Heavy Industries used VectorCAST to efficiently automate unit testing for the vision module, document everything in line with IEC 62304, and significantly ease the developers’ day-to-day workload.
State-of-the-art robotics in the operating room means complex embedded software, the highest safety requirements, and strict regulatory demands. For the hinotori Vision Unit – responsible for near zero-latency display and overlay of endoscopic 3D images – Medicaroid chose the VectorCAST unit testing and coverage analysis tool. Key reasons included TÜV SÜD certification according to IEC 62304:2015 and comprehensive support for structural and code coverage across software safety classes A through C.
For the development team, VectorCAST delivered one main benefit: less manual testing effort and more confidence in daily work. Test cases are executed automatically, coverage is measured and prepared as HTML reports, and regression tests can be focused precisely on modified code segments thanks to change-based testing. Features such as semi-automatic test case generation and clearly structured reports were also rated by the team as “easy to use” and highly practical.
In addition, the Medical Device Compliance Kit with TOR, TQD, plus pre-defined test cases and templates reduces the effort required for documentation and audits: a clear advantage in an environment where traceability is often just as important as functionality.
The case study details how Medicaroid and Kawasaki Heavy Industries integrated VectorCAST into their development process, what experiences the engineers had, and how the next step toward CI/CT with Jenkins is planned. Download the PDF to see how you can achieve similar gains in efficiency and quality in your own MedTech projects.
