Journal Article


Fergal McCaffery
Derek Flood
Peter Rust


Computer Science

life cycle processes roadmap software organizations computer software software process improvement medical device software medical device standards iec 62304

Software Process Improvement & Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software (2015)

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.
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

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