Impact of Standards on the Role and Application of Traceability in the Medical Device Domain

Regan, Gilbert and McCaffery, Fergal and McDaid, Kevin and Flood, Derek (2012) Impact of Standards on the Role and Application of Traceability in the Medical Device Domain. In: EuroSPI Conference 2012 , 25-27 June 2012, Vienna, Austria.

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Abstract

Software failure in the medical device domain can lead to injury or death. Controlling this risk is fundamental to producing quality software. To produce quality software, an effective requirements and hazards traceability process is required. Hence traceability is central to medical device software development. It is also an essential requirement for regulatory approval. The necessity for traceability is reinforced by the medical device standards and guidelines. In this paper we outline how traceability is an important part of medical device software development, what standards contain reference to traceability, and which specific clauses within those standards companies should refer to when defining their traceability processes. We also summarise the findings obtained when a lightweight assessment method (Med-Trace), that we created, based upon the traceability practices within these standards, was implemented in two SME organizations.

Item Type:	Conference or Workshop Item (Paper)
Uncontrolled Keywords:	Medical devices; Traceability; Standards
Subjects:	Computer Science
Research Centres:	Regulated Software Research Centre
Depositing User:	Gilbert Regan
Date Deposited:	13 Sep 2012 11:15
Last Modified:	11 Nov 2014 16:10
URI:	https://eprints.dkit.ie/id/eprint/244

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