NDLI: An agile v-model for medical device software development to overcome the challenges with plan-driven software development lifecycles

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An agile v-model for medical device software development to overcome the challenges with plan-driven software development lifecycles

Content Provider	ACM Digital Library
Author	McCaffery, Fergal Richardson, Ita Cawley, Oisín Wang, Xiaofeng McHugh, Martin
Abstract	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.
Starting Page	12
Ending Page	19
Page Count	8
File Format	PDF
ISBN	9781467362825
Language	English
Publisher	Association for Computing Machinery (ACM)
Publisher Date	2013-05-20
Access Restriction	Subscribed
Subject Keyword	Medical device software Fda Safety critical V-model Agile Av-model
Content Type	Text
Resource Type	Article

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