Physical Sciences and Mathematics Commons^™

An Agile Implementation Within A Medical Device Software Organisation, Martin Mchugh, Fergal Mc Caffery, Garret Coady

Conference papers

Three surveys conducted over a 6 year period revealed that medical device software organisations have difficulties in the area of requirements management, namely accommodating changes in requirements. Medical device software is traditionally developed in accordance with a plan driven software development lifecycle (SDLC). These SDLCs are rigid and inflexible to changes once the requirements management stage has been completed. Agile methods are gaining momentum in non-regulated industries but as of yet, the adoption of these methods in regulated industries such as the medical device software domain remains low. This study presents an implementation of agile methods within a medical device …