Overview:
A medical device developer requested help developing custom software for a new type of heart monitoring device. Software development for medical devices was guided in part by 21 CFR Part 820, which provided the framework by which the software is designed, written, tested, modified and managed.

The software comprised a control system for the electromechanical portion of the device, a set of data collection and operator interface functions to display EKG, heartbeat, blood pressure and other parameters, and a diagnostic function containing the signal analysis algorithms needed to diagnose specific heart conditions. The software was written in Visual Basic and C++, using an Access database for storage of patient data.