The aim of my diploma thesis project is to analyse a clinical defibrillator called „Cardio Aid 360-B”, from quality management and quality assurance perspective. This is produced and sold by Innomed Medical ltd. In more details the topic is about usability development and documentation, which is mandatory at medical devices. The usability development of this device is closely linked to clinical evaluation and risk management process.
The usability engineering file containing the details of usability engineering and user interface design process of the device, and usability test related to user interface evaluation, elaborated with the help of the new applicable standard, which is IEC 62366-1:2015 Medical devices, Part 1: Application of usability engineering to medical devices. The device has been augmented with new features, therefore the update of the documents of the device was required.
The clinical defibrillator saves all events during operation to log files, and this source will be suitable for post-production monitoring. In my project I made a software in Qt framework and C++ language, which is able to process the generated binary log data from the device and loads in the database avoiding duplicated inserts. The database was created in Microsoft SQL Server Management Studio. With this solution the data process and handling will be much easier for the required task.