Efficient Data Analysis Software Development for Clinical Trials

This document is a technical report detailing the development of a software tool for the analysis of corneal topography data by Technolas Perfect Vision GmbH in collaboration with infoteam. The report outlines the initial situation where Technolas, a developer of medical devices for ophthalmology, required a compliant solution for clinical data analysis to meet regulatory approval standards. The objective was to create a stand-alone WPF application that facilitates data import, visualization, and comparison while adhering to IEC 62304 standards. The solution involved deploying a skilled team to ensure compliance with medical technology standards, preparing requirement specifications, and developing a software plan that included testing concepts. The report describes the design and development process of the application, which supports reading CSV data, visualizing it in two dimensions, comparing datasets, and exporting visualizations as PDFs. The final software tool was verified and delivered according to the defined process guidelines.