Our client had “Proof of Concept” level software with no established design controls. The software was needed for critical beta/clinical trial timeline. Our client’s success was dependent on meeting milestones with quality software.
Results: RND took over all aspects of the software including communications and firmware. RND established a design history file, configuration control, and a plan to meet the customer’s milestones. RND is currently meeting those milestones.

Capabilities Applied

  • FDA Part 820, Part 11
  • ISO 13485 Quality System
  • Software Lifecycle
  • Windows Development
  • Requirements Management
  • Project Management
  • Software Verification
  • Firmware/Embedded Programming


  • Instrument/Analyzer
  • WPF UI Design/Development
  • LIS Integration
  • Algorithm Analysis
  • Data Reduction
  • Database Development
  • Firmware/Embedded Devices

Technologies Used

  • Python
  • C#, WPF Development