Polarion for Medical Device Design Controls


 

UNEEG medical A/S was founded in 2005 to build disruptive technologies for improving the quality of life and personal safety of diabetics. In 2009 T&W Medical (also behind WS Audiology) became a majority shareholder and gave UNEEG access to superior knowledge on wearable technologies. Today UNEEG is focused on epileptics as well as diabetics.

In 2018 UNEEG Medical realized they had a challenge in keeping their design in control. They had about a hundred different design documents per product that all had to be kept up to date. Keeping the traceability between all this information in order and managing the impact of changes was proving even more cumbersome. They had to do something to improve the situation!

After understanding their needs, learning what others had done and careful investigation of possible solutions they decided to trust on Taipuva and Polarion tool to help them overcome this challenge.

 

Today UNEEG Medical has deployed Polarion to majority of their Design Control processes including

  • Requirements management – including all product and software requirements
  • Architecture design documentation
  • Verification and validation (V&V) – planning, executing and reporting
  • Defect management
  • Risk management

 

In their own words they have received the following benefits with Polarion

  • Speeding up the design process by enabling working on different architectural levels at the same time instead of closing one document at a time
  • Clear visibility, transparency and control over all the documentation as it is all in the same tool
  • Impact analysis of changes or failing test cases made easy
  • No work needed for managing traceability
  • Fast reviews as focus can be on content instead of traceability etc.
  • Real time visual reporting of overall engineering status to all interested parties
  • Saving time and effort by reusing the existing documentation when starting to create new versions or variants

 

According to Flemming Jørgensen “Taking Polarion into use was easier than expected”. “Getting Polarion in to full use took only 3 months and it could have been even faster if prioritized higher”. He also highlights that “Taipuva has helped us a lot with ideas how to set up processes and work with Polarion”. He is very happy because Taipuva “wishes to understand our needs and propose solutions rather than implement something that will not work”

 

See a video interview with Flemming Jørgensen, System Architect at UNEEG Medical

Full interview available here

 

Would you like to know how we could help you? Book a free 30-minute consultation session!

Back to references
x

Contact us







Please prove you are human by selecting the Star.