On the impact of medical device regulations on software architecture

Research output: Chapter in Book/Report/Conference proceeding › Article in proceedings › Research › peer-review

Standard

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. Vol. 5 SCITEPRESS Digital Library, 2016. p. 389-394.

Research output: Chapter in Book/Report/Conference proceeding › Article in proceedings › Research › peer-review

Harvard

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

APA

Hansen, K. M., & Manikas, K. (2016). On the impact of medical device regulations on software architecture. In Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF (Vol. 5, pp. 389-394). SCITEPRESS Digital Library. https://doi.org/10.5220/0005776803890394

Vancouver

Hansen KM, Manikas K. On the impact of medical device regulations on software architecture. In Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF. Vol. 5. SCITEPRESS Digital Library. 2016. p. 389-394 https://doi.org/10.5220/0005776803890394

Author

Hansen, Klaus Marius ; Manikas, Konstantinos. / On the impact of medical device regulations on software architecture. Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF. Vol. 5 SCITEPRESS Digital Library, 2016. pp. 389-394

Bibtex

@inproceedings{585e8a6c8e5949f89165b475a8a0c5e1,
title = "On the impact of medical device regulations on software architecture",
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.",
author = "Hansen, {Klaus Marius} and Konstantinos Manikas",
year = "2016",
doi = "10.5220/0005776803890394",
language = "English",
volume = "5",
pages = "389--394",
booktitle = "Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF",
publisher = "SCITEPRESS Digital Library",
note = "International Conference of Health Informatics, HEALTHINF ; Conference date: 21-02-2016 Through 23-02-2016",

}

RIS

TY - GEN

T1 - On the impact of medical device regulations on software architecture

AU - Hansen, Klaus Marius

AU - Manikas, Konstantinos

N1 - Conference code: 9

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

U2 - 10.5220/0005776803890394

DO - 10.5220/0005776803890394

M3 - Article in proceedings

VL - 5

SP - 389

EP - 394

BT - Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF

PB - SCITEPRESS Digital Library

T2 - International Conference of Health Informatics

Y2 - 21 February 2016 through 23 February 2016

ER -

ID: 167580964