We utilise Pro R for structuring and tracking requirements.
We model the HD machine using i UML-B state-machines and class diagrams, and build a corresponding BMotion Studio visualisation.
We conclude that the Event-B based modelling tools are particularly rich in verification and validation techniques and with the help of supporting tools for requirements tracking, are able to address the different kinds of requirements in a medical device.
Verification - to establish the truth of the correspondence between a software product and its specification.
This can happen when, say, a product is built as per the specifications but the specifications themselves fail to address the user's needs.