Codan Argus develops infusion pumps, which it sells worldwide. The company wanted to replace an existing product and, to meet medical device licensing requirements, needed to make changes to its software development process. To guarantee patient safety, infusion pumps have to meet strict safety requirements. Software and the software development process make a key contribution to safety.
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 processes integrated seamlessly into Codan Argus’ existing quality assurance system.