Zuhlke analysed the existing process framework and identified gaps where the new requirements, primarily defined by ISO 62304, were not being met. Thanks to extensive project experience, the team was able to define the processes such that enough latitude remained for efficient workflows. The new workflows permitted the agile integration of amended or specific customer requirements. The new processes integrated seamlessly into Codan Argus’ existing quality assurance system. Zuhlke produced a new requirements list for the tools, which helped ensure process conformity and, by providing ongoing feedback, improved software quality.