"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, documentation and FDA compliance. They were a key member of our team in eventually getting FDA clearance for our Class III device.”

TriPath Imaging is involved in the research, development and commercialization of technologies used in the detection of cervical cancer.

TriPath needed FDA compliant software development and validation that would allow their Automated Slide Preparation System used in GYN and non-GYN cancer screening to be submitted to the FDA for approval.

Code Refinery’s team was able to quickly assess the requirements of the customer and determine the most effective development and validation plan in order to meet TriPath’s product release objectives.

Throughout the processes, Code Refinery maintained strict adherence to FDA regulations and standards and provided guidance on issues related to software validation for Class 3 medical device pre-market approval. We facilitated clear, effective communication among project teams and assisted in formalizing the software development life cycle procedures.

After analyzing the project’s risks and creating a clear plan, Code Refinery followed the project to its completion by managing test execution and providing a formal test report.