Because it is supremely important that the software developed for a medical device provides the services defined by its specification we ensure that a comprehensive specification for the software is developed in conjunction with real users of the system. These are the people who understand, far better than an engineer, how the system being designed should be deployed in a medical environment. They are especially aware of their own protocols for the use of devices and how the system should best appear to a user.
Developing systems alongside obtaining user feedback inevitably means that the specifications will be subject to change. Changes are to be expected during the design life of a complex system. When dealing with safety critical equipment, it is important that the impact of proposed changes is assessed by the development team. Evidence must be provided that proper procedures were in place to prove that due consideration and responsibility were exercised. Changes and incremental enhancements in a system's behaviour are properly accommodated in a thoroughly undertaken development process supported by change management tools.
We ensure that the system under development meets its specifications exactly by tracing the requirements through to design and implementation. To verify that the correct product is being built, we use a modelling tool to experiment with the specification at the earliest opportunity in its lifecycle. The use of models in system development provides the means to demonstrate that each requirement has been satisfied. Not only do models offer similar mechanisms for evaluating specifications to those employed by other engineering disciplines, they also provide "tags" that may help establish the full tracing required.
To ensure that the product is developed appropriately we use rigorous processes, backed up by best in market tools and techniques. These methods allow flexibility and sound decision guidance throughout the development lifecycle.
We discuss the techniques that we employ more fully in our range of white papers and our article published in European Medical Device Technology magazine.