Sterling Medical Devices participated in the development of a prognostic genetic test for cancer patients.
In the first project phase, we authored select Design History File (DHF) documentation including the Software Requirements Specification, a Hazard Analysis, and an Off-the-Shelf Analysis. We also developed a GUI prototype.
In phase two, Sterling developed the software using the Microarray SDK. The software interacts with users via an assay-specific GUI and retrieves data from the Microarray platform. A number of functions are performed on the data including advanced calculation, FFPE correction, classification, outlier detection. Additionally, the system makes quality control decisions through the application of MAS 5, RMA, and DCHIP algorithms. In addition to this software development we completed unit module tests, code review, risk mitigation and residual risk analysis.
Documentation and development was performed under Sterling’s QMS then transferred to the client’s QMS.