Development and Conformity Assessment of ECG-Photometric Complex Software

Abstract

Introduction. The article is devoted to the software "PulseWave", which is used as part of the ECG-photometric complex for research in medical institutions. For further implementation of the complex in medical practice, it is necessary to assess the compliance of this software in accordance with the requirements of the technical regulations for medical devices. There are two ways to perform software conformity assessment: as part of the ECG photometric complex or separately from it (stand alone). In this paper, the option of conducting a stand alone conformity assessment was chosen, i.e. as a separate product. This approach is the most promising, given the development of "cloud" storage and data processing environments and the need to introduce into medical practice of treatment and prevention facilities in Ukraine. The purpose of the article is to develop software and prepare it for conformity assessment in accordance with the requirements of the technical regulations for medical devices. Results. The authors consider the structure and principle of operation of the software "PulseWave" ECG-photometric complex. The main stages of the life cycle of this software according to international standards are given. A risk assessment report has been developed, which shows and evaluates the main errors that may occur in the work of the software; and ways to eliminate them. Conclusions. The software development, development of its life cycle and risk analysis provide an opportunity to start the procedure of assessing its compliance with the requirements of the technical regulations for medical devices in accordance with international standards.

Keywords

• software
• conformity assessment
• life cycle
• application risks