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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 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 …