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Authors: Klaus Marius Hansen and Konstantinos Manikas

Affiliation: University of Copenhagen, Denmark

Keyword(s): Medical Device, Regulation Compliance, Software Architecture.

Related Ontology Subjects/Areas/Topics: Biomedical Engineering ; Design and Development Methodologies for Healthcare IT ; Electronic Health Records and Standards ; Health Information Systems ; Software Systems in Medicine

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.

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Paper citation in several formats:
Hansen, K. and 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 (BIOSTEC 2016) - HEALTHINF; ISBN 978-989-758-170-0; ISSN 2184-4305, SciTePress, pages 389-394. DOI: 10.5220/0005776803890394

@conference{healthinf16,
author={Klaus Marius Hansen. and Konstantinos Manikas.},
title={On the Impact of Medical Device Regulations on Software Architecture},
booktitle={Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2016) - HEALTHINF},
year={2016},
pages={389-394},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0005776803890394},
isbn={978-989-758-170-0},
issn={2184-4305},
}

TY - CONF

JO - Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2016) - HEALTHINF
TI - On the Impact of Medical Device Regulations on Software Architecture
SN - 978-989-758-170-0
IS - 2184-4305
AU - Hansen, K.
AU - Manikas, K.
PY - 2016
SP - 389
EP - 394
DO - 10.5220/0005776803890394
PB - SciTePress

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