research-article

Engineering high confidence medical device software

Authors:

Arnab Ray,

Raoul Jetley,

Paul JonesAuthors Info & Claims

ACM SIGBED Review, Volume 6, Issue 2

Article No.: 1, Pages 1 - 7

https://doi.org/10.1145/1859823.1859824

Published: 01 July 2009 Publication History

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Abstract

The increasing complexity of medical device software has created new challenges in ensuring that a medical device operates correctly. This paper discusses how two technologies---model-based development and static analysis---may be used to facilitate the successful engineering of medical software and some possible regulatory side benefits.

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Cited By

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Maldonado Belmonte EOtón Tortosa SRuggia Frick R(2021)Proposal for a Standard Architecture for the Integration of Clinical Information Systems in a Complex Hospital EnvironmentInformatics10.3390/informatics80400878:4(87)Online publication date: 15-Dec-2021
https://doi.org/10.3390/informatics8040087

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A wide variety of the functions provided by today's medical devices relies heavily on soft ware. Most of these capabilities could not be offered without the underlying integrated software solutions. As a result, the medical device industry has become ...

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Published In

ACM SIGBED Review Volume 6, Issue 2

Special Issue on the 2nd Joint Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug-and-Play (MD PnP) Interoperability

July 2009

95 pages

EISSN:1551-3688

DOI:10.1145/1859823

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Association for Computing Machinery

New York, NY, United States

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Published: 01 July 2009

Published in SIGBED Volume 6, Issue 2

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Maldonado Belmonte EOtón Tortosa SRuggia Frick R(2021)Proposal for a Standard Architecture for the Integration of Clinical Information Systems in a Complex Hospital EnvironmentInformatics10.3390/informatics80400878:4(87)Online publication date: 15-Dec-2021
https://doi.org/10.3390/informatics8040087

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Abstract

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Index Terms

Recommendations

Certification and regulatory challenges in medical device software development

High-Confidence Medical Device Software and Systems

A Survey of Software Engineering Techniques in Medical Device Development

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