@inproceedings{1e2df6a3cae445708c7fedbdc532d6da,
title = "An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles",
abstract = "Through the use of semi structured interviews with medical device software organizations it emerged that medica device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC) particularly in the area of requirements management. To attemp 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.",
keywords = "A V-Model, Agile, FDA, Medical Device Software, Model, Safety Critical, V",
author = "{Mc Hugh}, Martin and Oisin Cawley and Fergal McCaffcry and Ita Richardson and Xiaofeng Wang",
year = "2013",
doi = "10.1109/SEHC.2013.6602471",
language = "English",
isbn = "9781467362825",
series = "2013 5th International Workshop on Software Engineering in Health Care, SEHC 2013 - Proceedings",
pages = "12--19",
booktitle = "2013 5th International Workshop on Software Engineering in Health Care, SEHC 2013 - Proceedings",
note = "2013 5th International Workshop onSoftware Engineering in Health Care, SEHC 2013 ; Conference date: 20-05-2013 Through 21-05-2013",
}