The PrepStain

BD Automated Slide Staining System

BD is a global medical technology company that focuses on improving drug delivery, enhancing the diagnosis of infectious diseases and cancers, and advancing drug discovery. BD acquired TriPath Imaging, Inc., a global cancer diagnostics company, in 2006.

Project: BD PrepStain Slide Processor Software Application

Challenge:  Create an FDA-compliant software for an automated slide preparation system used in cytology screening.

Results Delivered:

Code Refinery took the following actions:

  • Quickly assessed the project requirements and implemented an efficient development and validation plan to meet the product release objectives.
  • Followed FDA regulations and provided guidance on issues related software validation for a Class III medical device premarket clearance.
  • Established formal software development procedures which facilitated clear, effective communication among teams.

BD received FDA clearance to market the Class III PrepStain system.

Code Refinery had a good working knowledge of our equipment and instrumentation. They clearly understood our project objectives and gave us a complete solution from software development to documentation and FDA compliance. They were a key member of our team in eventually getting FDA clearance for our Class III device.”

—Senior Scientist, Cervical Programs, BD Diagnostics, TriPath


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