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Lean Compliance

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.

Customer Benefits

  • Compliance with the latest regulatory requirements for medical technology.
  • Greater transparency thanks to regular reports.
  • Software development has been seamlessly integrated into existing business processes, increasing acceptance across the company.

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. To guarantee patient safety, infusion pumps have to meet strict safety requirements. Software and the software development process make a key contribution to safety.

Solution

Zühlke 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.

 

Photo: Mr Thorsten Knauf

Thorsten Knauf

Director Business Development, Partner
Medtech