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Success Story

New software process results in better medical devices

In response to strict regulatory requirements, as part of the process of developing a new infusion pump, Codan Argus found itself in the position of needing to upgrade its software development processes. Zuhlke analysed and optimised the existing workflows.

Task

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. Zuhlke analysed existing workflows and specified how processes could be made to conform to regulatory requirements (ISO 62304). To guarantee patient safety, infusion pumps have to meet strict safety requirements. Software and the software development process make a key contribution to safety. The project team initiated and assisted with the introduction of substantially automated development processes, including the introduction of the required tools.

Solution

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.

 

Client benefits

  • Zuhlke’s experience enabled the client to comply with the latest regulatory requirements for medical technology.
     
  • Efficient, tool-supported implementation of its software development processes enabled Codan Argus to rapidly respond to specific requirements from its customers. Thanks to regular reports, the changes have also resulted in greater transparency.
     
  • Software development has been seamlessly integrated into existing business processes, increasing acceptance across the company.

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