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A Software Process Improvement Roadmap for IEC 62304: an Expert Review

Rust, Peter and Flood, Derek and Regan, Gilbert and McCaffery, Fergal (2018) A Software Process Improvement Roadmap for IEC 62304: an Expert Review. Communications in Computer and Information Science, 896. pp. 593-604. ISSN 1865-0929

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Abstract

Manufacturers of medical devices must comply with certain legislation and regulations before they can market their products in the European Union (EU). The EU has introduced this legislation and regulation to provide the frameworks by which manufacturers can produce safe and effective medical devices in a consistent manner. The EU has accomplished this by way of Medical Device Directives and harmonised standards. Manufactures, by demonstrating compliance with a harmonised standard, can be presumed to have complied with the essential requirements of the legislation. IEC 62304 Medical device software – Software lifecycle processes is a harmonised standard. However, the standard provides no clear directions for meeting the requirements of the standard. A Software Process Improvement (SPI) Roadmap for IEC 62304:2006 has been developed as a method for aiding medical device software development organizations in implementing the standard. The Roadmap is divided into two levels, the high level consists of the Activities and Tasks necessary for the im-plementation of the standard, while the low level contains the Design Patterns and How-to artefacts linked to the Tasks. This paper presents the findings from the expert review of the high level roadmap.

Item Type: Article
Subjects: Computer Science > Computer Software
Research Centres: Regulated Software Research Centre
Depositing User: Peter Rust
Date Deposited: 16 Jan 2019 23:43
Last Modified: 16 Jan 2019 23:43
License: Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI: http://eprints.dkit.ie/id/eprint/626

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