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.
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