Clinical risk evaluation of medical device software: an axiomatic design-based methodology

The increasing complexity of medical device (MD) management software requires the adoption of new methodological approaches that pay particular attention to safety issues. The risk analysis is one of the key activities to be carried out by the manufacturer before the development of the software appl...
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Autor*in:	Rolli Fernando [verfasserIn] Pecoraro Fabrizio [verfasserIn] Luzi Daniela [verfasserIn] Ricci Fabrizio L. [verfasserIn] Pourabbas Elaheh [verfasserIn] Parretti Chiara [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch ; Französisch

Erschienen:	2019

Übergeordnetes Werk:	In: MATEC Web of Conferences - EDP Sciences, 2013, 301, p 00005(2019)
Übergeordnetes Werk:	volume:301, p 00005 ; year:2019

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1051/matecconf/201930100005

Katalog-ID:	DOAJ056178344

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language	English French
source	In MATEC Web of Conferences 301, p 00005(2019) volume:301, p 00005 year:2019
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authorswithroles_txt_mv	Rolli Fernando @@aut@@ Pecoraro Fabrizio @@aut@@ Luzi Daniela @@aut@@ Ricci Fabrizio L. @@aut@@ Pourabbas Elaheh @@aut@@ Parretti Chiara @@aut@@
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title	Clinical risk evaluation of medical device software: an axiomatic design-based methodology
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title_auth	Clinical risk evaluation of medical device software: an axiomatic design-based methodology
abstract	The increasing complexity of medical device (MD) management software requires the adoption of new methodological approaches that pay particular attention to safety issues. The risk analysis is one of the key activities to be carried out by the manufacturer before the development of the software application as it determines the type of documentation to be provided as well as the activities to be performed to place the MD on the market. After the definition of software requirements and their iterative transformation into architectural items and/or units, the manufacturer defines the safety class of each item. The adoption of an axiomatic design approach facilitates this process. This combination of techniques helps to focus the design of medical device software on non-conformities with a clear link to clinical risk. This objective can be achieved by assessing the complexity of the system to be designed, both in terms of its functional size, and as a level of overall clinical risk. In this multi-dimensional perspective, the software effort expressed in function points provides an estimate of the development cost. While the clinical risk analysis allows to quickly identify critical areas, to intervene with the same promptness and to draft a management plan according to the regulations of the various control authorities.
abstractGer	The increasing complexity of medical device (MD) management software requires the adoption of new methodological approaches that pay particular attention to safety issues. The risk analysis is one of the key activities to be carried out by the manufacturer before the development of the software application as it determines the type of documentation to be provided as well as the activities to be performed to place the MD on the market. After the definition of software requirements and their iterative transformation into architectural items and/or units, the manufacturer defines the safety class of each item. The adoption of an axiomatic design approach facilitates this process. This combination of techniques helps to focus the design of medical device software on non-conformities with a clear link to clinical risk. This objective can be achieved by assessing the complexity of the system to be designed, both in terms of its functional size, and as a level of overall clinical risk. In this multi-dimensional perspective, the software effort expressed in function points provides an estimate of the development cost. While the clinical risk analysis allows to quickly identify critical areas, to intervene with the same promptness and to draft a management plan according to the regulations of the various control authorities.
abstract_unstemmed	The increasing complexity of medical device (MD) management software requires the adoption of new methodological approaches that pay particular attention to safety issues. The risk analysis is one of the key activities to be carried out by the manufacturer before the development of the software application as it determines the type of documentation to be provided as well as the activities to be performed to place the MD on the market. After the definition of software requirements and their iterative transformation into architectural items and/or units, the manufacturer defines the safety class of each item. The adoption of an axiomatic design approach facilitates this process. This combination of techniques helps to focus the design of medical device software on non-conformities with a clear link to clinical risk. This objective can be achieved by assessing the complexity of the system to be designed, both in terms of its functional size, and as a level of overall clinical risk. In this multi-dimensional perspective, the software effort expressed in function points provides an estimate of the development cost. While the clinical risk analysis allows to quickly identify critical areas, to intervene with the same promptness and to draft a management plan according to the regulations of the various control authorities.
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title_short	Clinical risk evaluation of medical device software: an axiomatic design-based methodology
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Clinical risk evaluation of medical device software: an axiomatic design-based methodology

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