Case Studies
Code Refinery is a dependable, customer-focused company that has achieved success through focusing on providing our customers peace of mind during the FDA software compliance process. By taking a comprehensive approach, we build solutions that integrate into your environment and grow with your business needs. With an emphasis on FDA regulated systems, we solve problems in a variety of critical applications.

Our customers include global leaders in life sciences, clinical diagnostics and medical device. Here are just some of Code Refinery's satisfied customers and selected case studies:

Upgrading OS of FDA cleared plasma screening systems extends service while minimizing impact to production and cost.

Air tight documentation and testing of viral meningitis diagnostic system, results in solid foundation for further development.

FDA 510(k) clearance received for the NucliSens EasyQ Enterovirus System.

Fully integrated infant formula QC System improved sample throughput and flexible workflow

ISBT 128 barcode support for for HIV-1, HCV, HBV and West Nile Virus screening system meets global standard for FDA approved software.

Integrated flavor research system results in decreased development time and increases flavor creation.

Genotyping system automates labor intensive protocols for Human Genome Research project.

FDA 510 (k) marketing approval achieved for automated system used to screen for HIV, HIV-1/HCV, HBV and West Nile Virus.

FDA marketing clearance achieved for Automated slide preparation system used in cervical cancer screening

Case Studies

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