Our customer needed a revised web application that was fully FDA compliant, localizable to many languages, designed with newer UI styles and most importantly an accurate implementation of the algorithm used for diagnosis.
Tietronix worked with our customer to identify the gaps in their current application, developed an action plan and re-implemented the application under full FDA design controls to meet the customer requirements. We designed a modern interface for the application, analyzed and addressed risks, re-implemented the algorithm, and thoroughly tested the application. Formative and summative usability studies were performed. The application launched successfully in Europe with CE mark in 2015.