Type

Journal Article

Authors

Fergal McCaffery
Gilbert Regan
Derek Flood
Peter Rust

Subjects

Computer Science

Topics
medical devices computer software software process improvement medical device software the european union software process improvement spi iec 62304 medical software development

A Software Process Improvement Roadmap for IEC 62304: an Expert Review (2018)

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.
Collections Ireland -> Dundalk IT -> Subject = Computer Science: Computer Software
Ireland -> Dundalk IT -> Status = Published
Ireland -> Dundalk IT -> Type = Article

Full list of authors on original publication

Fergal McCaffery, Gilbert Regan, Derek Flood, Peter Rust

Experts in our system

1
Fergal McCaffery
Dundalk IT
Total Publications: 91
 
2
Gilbert Regan
Dundalk IT
Total Publications: 17
 
3
Derek Flood
Dundalk IT
Total Publications: 30
 
4
Peter Rust
Dundalk IT
Total Publications: 6