On the impact of medical device regulations on software architecture

Klaus Marius Hansen; Konstantinos Manikas

doi:10.5220/0005776803890394

On the impact of medical device regulations on software architecture

Klaus Marius Hansen, Konstantinos Manikas

Datalogisk Institut

2 Citationer (Scopus)

Abstract

Compliance to regulations and regulatory approval are requirements for many medical device software systems. In this paper, we investigate the implications of medical device software regulations to the design of software systems. We do so by focusing on the American and European regulatory authorities and review the legal requirements for regulatory approval of medical devices. We define a simplified process for regulatory approval, consisting of five steps, and enhance this process by descriptions of how to decide whether a software system is a medical device and how to identify the class of the device. Moreover, we review software modularity in the implementation of software medical device and propose a set of preliminary principles for architectural design of software medical device based on a set of constrains identified from the reviewed regulations.

Originalsprog	Engelsk
Titel	Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF
Antal sider	6
Vol/bind	5
Forlag	SCITEPRESS Digital Library
Publikationsdato	2016
Sider	389-394
ISBN (Elektronisk)	978-989-758-170-0
DOI	https://doi.org/10.5220/0005776803890394
Status	Udgivet - 2016
Begivenhed	International Conference of Health Informatics - Rome, Italien Varighed: 21 feb. 2016 → 23 feb. 2016 Konferencens nummer: 9

Konference

Konference	International Conference of Health Informatics
Nummer	9
Land/Område	Italien
By	Rome
Periode	21/02/2016 → 23/02/2016

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10.5220/0005776803890394

On the Impact of Medical Device Regulations on Software ArchitectureIndsendt manuskript, 307 KB

Citationsformater

On the impact of medical device regulations on software architecture. / Hansen, Klaus Marius; Manikas, Konstantinos.

Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF. Bind 5 SCITEPRESS Digital Library, 2016. s. 389-394.

Publikation: Bidrag til bog/antologi/rapport › Konferencebidrag i proceedings › Forskning › peer review

Hansen, KM & Manikas, K 2016, On the impact of medical device regulations on software architecture. i Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF. bind 5, SCITEPRESS Digital Library, s. 389-394, International Conference of Health Informatics, Rome, Italien, 21/02/2016. https://doi.org/10.5220/0005776803890394

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On the impact of medical device regulations on software architecture

Abstract

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