Invent

Gen-Probe


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Gen-Probe is a global leader in the development, manufacturing, and marketing of molecular diagnostics products and

services that are used to diagnose human diseases, screen donated blood, ensure transplant compatibility, and aid biomedical research.

Project: Implement ISBT 128 barcode standard into an FDA-cleared software application.

Challenge:

  • Implement ISBT 128 barcode support into a instrument software application used to screen for HIV-1, HCV, HBV and West Nile viruses in donated blood.
  • Ensure development effort will be executed under a formal design controls to meet FDA medical device regulations.
  • Deliver final software with full documentation and verification.

Results Delivered:

  • Implemented ISBT 128 barcode support into the software application.
  • Delivered complete documentation of all development and verification activities.
  • Development effort was executed under design controls and met FDA medical device regulations.

 

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