Type

Journal Article

Authors

Fergal McCaffery
Derek Flood
Peter Rust

Subjects

Computer Science

Topics
process of implementation software process improvement roadmaps life cycle processes computer software the european union medical device software medical device standards medical software development

Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304 (2015)

Abstract One stated objective of the European Union is to encourage SME’s expand their area of operation into other domains. The medical device domain is one such domain identified by the EU. Medical device software development must be carried out in a manner that compliance with certain medical device standards and regulations can be demonstrated. 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. SME software development organizations wishing to expand their operations into the medical device software development domain face serious challenges in demonstrating compliance with IEC 62304. The standard describes the set of processes, activities, and tasks that are required to be carried out, but importantly do not describe how they should be carried out. This paper describes the development of a roadmap that will aid software development SME’s, entering the medical device software development domain, by the use of design patterns to generate “How-to” artefacts, overcome the challenge of demonstrating compliance.
Collections Ireland -> Dundalk IT -> Subject = Computer Science: Computer Software
Ireland -> Dundalk IT -> Open Access DRIVERset
Ireland -> Dundalk IT -> Status = Published
Ireland -> Dundalk IT -> Type = Article

Full list of authors on original publication

Fergal McCaffery, Derek Flood, Peter Rust

Experts in our system

1
Fergal McCaffery
Dundalk IT
Total Publications: 91
 
2
Derek Flood
Dundalk IT
Total Publications: 30
 
3
Peter Rust
Dundalk IT
Total Publications: 6