404 Use Case - Medical certification and Requirements management Framework

Use Case Application:
  • The use cases of Barco address the development of medical display systems, such as the monitor shown on the picture above. The market for such display systems is rapidly changing. Not only is there an increasing complexity of new medical regulations and certification requirements (driven partially by emerging countries), but the market also requires more and more product variants that are tailored for specific clinical applications. Also from a technological point of view, new emerging technologies such as HTML/5 and cloud computing are forcing a shift from hardware (FPGA) based development towards software centric development. This leads to two use cases. WP4.4 handles the increasing complexity of medical certification and requirement management. Adapting to an interoperable tool chain will make it possible to cope with an ever increasing amount of regulations and requirements, while at the same time improving efficiency of the development and validation processes.
Main Methods and Tools:
  • Requirement Management: PTC Integrity
  • Test Management: PTC Integrity
  • Defect management: Jira/iTrack
  • Risk Management: PTC Integrity
Expected results:
  • Requirements traceability throughout the development process, leading to consistent traceable documentation.
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