loading
Papers Papers/2022 Papers Papers/2022

Research.Publish.Connect.

Paper

Paper Unlock

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.

CC BY-NC-ND 4.0

Sign In Guest: Register as new SciTePress user now for free.

Sign In SciTePress user: please login.

PDF ImageMy Papers

You are not signed in, therefore limits apply to your IP address 3.140.192.173

In the current month:
Recent papers: 100 available of 100 total
2+ years older papers: 200 available of 200 total

Paper citation in several formats:
Hansen, K. M. 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

- Science and Technology Publications, Lda.
RESOURCES

Proceedings

Papers

Authors

Ontology

CONTACTS

Science and Technology Publications, Lda
Avenida de S. Francisco Xavier, Lote 7 Cv. C,
2900-616 Setúbal, Portugal.

Phone: +351 265 520 185 (National fixed network call)
Fax: +351 265 520 186
Email: info@scitepress.org

EXTERNAL LINKS

PRIMORIS

INSTICC

SCITEVENTS

CROSSREF

PROCEEDINGS SUBMITTED FOR INDEXATION BY:

dblp

Ei Compendex

SCOPUS

Semantic Scholar

Google Scholar

Microsoft Academic