Development and Conformity Assessment of ECG-Photometric Complex Software

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 accordanc...

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Autores principales:	Vitalii Budnyk, Tetiana Ryzhenko, Mykola Budnyk
Formato:	article
Lenguaje:	EN RU UK
Publicado:	V.M. Glushkov Institute of Cybernetics 2021
Materias:	software conformity assessment life cycle application risks Cybernetics Q300-390
Acceso en línea:	https://doaj.org/article/18efd387efa140c48745514ffa5f5491
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spelling	oai:doaj.org-article:18efd387efa140c48745514ffa5f54912021-11-08T19:44:55ZDevelopment and Conformity Assessment of ECG-Photometric Complex Software2707-45012707-451X10.34229/2707-451X.21.3.10https://doaj.org/article/18efd387efa140c48745514ffa5f54912021-09-01T00:00:00Zhttp://cctech.org.ua/13-vertikalnoe-menyu-en/293-abstract-21-3-10-artehttps://doaj.org/toc/2707-4501https://doaj.org/toc/2707-451XIntroduction. 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.Vitalii BudnykTetiana RyzhenkoMykola BudnykV.M. Glushkov Institute of Cyberneticsarticlesoftwareconformity assessmentlife cycleapplication risksCyberneticsQ300-390ENRUUKКібернетика та комп'ютерні технології, Iss 3, Pp 115-128 (2021)
institution	DOAJ
collection	DOAJ
language	EN RU UK
topic	software conformity assessment life cycle application risks Cybernetics Q300-390
spellingShingle	software conformity assessment life cycle application risks Cybernetics Q300-390 Vitalii Budnyk Tetiana Ryzhenko Mykola Budnyk Development and Conformity Assessment of ECG-Photometric Complex Software
description	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.
format	article
author	Vitalii Budnyk Tetiana Ryzhenko Mykola Budnyk
author_facet	Vitalii Budnyk Tetiana Ryzhenko Mykola Budnyk
author_sort	Vitalii Budnyk
title	Development and Conformity Assessment of ECG-Photometric Complex Software
title_short	Development and Conformity Assessment of ECG-Photometric Complex Software
title_full	Development and Conformity Assessment of ECG-Photometric Complex Software
title_fullStr	Development and Conformity Assessment of ECG-Photometric Complex Software
title_full_unstemmed	Development and Conformity Assessment of ECG-Photometric Complex Software
title_sort	development and conformity assessment of ecg-photometric complex software
publisher	V.M. Glushkov Institute of Cybernetics
publishDate	2021
url	https://doaj.org/article/18efd387efa140c48745514ffa5f5491
work_keys_str_mv	AT vitaliibudnyk developmentandconformityassessmentofecgphotometriccomplexsoftware AT tetianaryzhenko developmentandconformityassessmentofecgphotometriccomplexsoftware AT mykolabudnyk developmentandconformityassessmentofecgphotometriccomplexsoftware
_version_	1718441450640769024

Development and Conformity Assessment of ECG-Photometric Complex Software

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