RND was to develop the software for the first fully automated molecular diagnostic instrument.  We were to manage all aspects of software requirements, design, implementation, and verification of a moderate and major level of concern device.  RND was to develop user interface, database, LIS, device control, reports, etc.
RND managed and delivered all aspects of the project from requirements development through requirements management, design, implementation, and verification. The product  has been approved by the FDA for use in the clinical market.  RND continues to participate in the lifecycle management of the product as it is modified to meet the requirements for other markets.

Capabilities Applied

  • FDA Part 821, Part 11
  • ISO 13485 Quality System
  • Software Lifecycle
  • Windows Development
  • Requirements Management
  • Project Management
  • Software Verification


  • Instrument/Analyzers
  • User Interface design/development
  • LIS Integration
  • Algorithm Analysis
  • Data Reduction
  • Remote Diagnostics
  • Firmware/Embedded Development
  • Database Development

Technologies Used

  • Visual Studio/C++/C