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Authors: Derek Flood ; Fergal Mc Caffery and Valentine Casey

Affiliation: Dundalk Institute of Technology, Ireland

Keyword(s): Medical Devices, Software Process Improvement, Roadmaps, Quality Management System.

Related Ontology Subjects/Areas/Topics: Biomedical Engineering ; Cloud Computing ; Design and Development Methodologies for Healthcare IT ; e-Health ; Health Information Systems ; Platforms and Applications

Abstract: In recent years the proportion and complexity of software in medical devices has increased considerably. This has presented an opportunity for software development organisations to expand into the medical device domain. Due to the high level of risk associated with medical devices, strict regulations must be adhered to in order to market such products. One key aspect of these regulations is the necessity to have in place a Quality Management System to help ensure an organisations’ ability to consistently meet customer and regulatory requirements. This paper presents a roadmap which can be used to assist organisations, wishing to develop medical device software to implement a Quality Management System.

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Paper citation in several formats:
Flood, D.; Mc Caffery, F. and Casey, V. (2013). A Roadmap to Implement a Quality Management System. In Proceedings of the International Conference on Health Informatics (BIOSTEC 2013) - HEALTHINF; ISBN 978-989-8565-37-2; ISSN 2184-4305, SciTePress, pages 133-138. DOI: 10.5220/0004183601330138

@conference{healthinf13,
author={Derek Flood. and Fergal {Mc Caffery}. and Valentine Casey.},
title={A Roadmap to Implement a Quality Management System},
booktitle={Proceedings of the International Conference on Health Informatics (BIOSTEC 2013) - HEALTHINF},
year={2013},
pages={133-138},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0004183601330138},
isbn={978-989-8565-37-2},
issn={2184-4305},
}

TY - CONF

JO - Proceedings of the International Conference on Health Informatics (BIOSTEC 2013) - HEALTHINF
TI - A Roadmap to Implement a Quality Management System
SN - 978-989-8565-37-2
IS - 2184-4305
AU - Flood, D.
AU - Mc Caffery, F.
AU - Casey, V.
PY - 2013
SP - 133
EP - 138
DO - 10.5220/0004183601330138
PB - SciTePress

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