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An Agile V-Model for Medical Device Software Development to Overcome the Challenges with Plan Driven SDLCs
McHugh, Martin; Cawley, Oisin; McCaffery, Fergal; Richardson, Ita; Wang, Xiaofeng
Through the use of semi structured interviews with medical device software organizations it emerged that medical device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC), particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software. This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success. This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical device software organizations. This research aims to develop a SDLC which has a foundation of a plan driven SDLC which incorporates agile practices which can be followed when developing regulatory compliant software.
Keyword(s): Medical Device Software; Safety Critical; V-Model; Agile; FDA; AV-Model; Computer Sciences
Publication Date:
2013
Type: Conference item
Peer-Reviewed: Unknown
Contributor(s): Science Foundation Ireland
Institution: Dublin Institute of Technology
Citation(s): Conference papers
Publisher(s): Dublin Institute of Technology
File Format(s): application/pdf
First Indexed: 2014-03-22 05:35:46 Last Updated: 2017-12-14 06:58:24