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Publication

A roadmap to implement a quality management system

Date
2013
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.
Supervisor
Description
peer-reviewed
Publisher
Citation
6th International conference on Health Informatics (Healthinf 2013);
Collections
Lero - The Science Foundation Ireland Research Centre for Software
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Files
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Flood_2013_roadmap.pdf
Adobe PDF, 54.6 KB
Keywords
medical devices, software process improvement, roadmaps, quality management system
ULRR Identifiers
https://researchrepository.ul.ie/handle/10344/3125
 https://doi.org/10.34961/705
Funding code
Funding Information
Science Foundation Ireland (SFI)
Sustainable Development Goals
External Link
Type
Meetings and Proceedings
Rights
https://creativecommons.org/licenses/by-nc-sa/1.0/
License