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Software Process Improvement & Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software

Rust, Peter and Flood, Derek and McCaffery, Fergal (2015) Software Process Improvement & Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software. Communications in Computer and Information Science. ISSN 1865-0929

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Abstract

Organizations engaged in medical device software are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed. One such standard IEC 62304, Medical device software -- Software life cycle processes, is a standard that defines the processes that are required to be executed in order to develop safe software. Demonstrating compliance with IEC 62304 can be problematic for organizations that are new to or have limited experience in the domain. The standard defines what processes must be carried out, but does not state how. This paper presents a research method for generating a roadmap that will guide organizations in the implementation of IEC 62304.

Item Type: Article
Uncontrolled Keywords: Medical device software; medical device standards; Regulatory compliance; Software roadmap; Software Process Improvement; Software Process Improvement Roadmaps; IEC 62304.
Subjects: Computer Science > Computer Software
Research Centres: Regulated Software Research Centre
Depositing User: Sean McGreal
Date Deposited: 11 Nov 2016 12:20
Last Modified: 11 Nov 2016 12:20
License: Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI: http://eprints.dkit.ie/id/eprint/546

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