This could be a challenge as a tool might be needed

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specification to each stage of the development process. This could be a challenge as a tool might be needed maintain traceability between the requirements and each stage of development whilst developing software in accordance with agile practices. Lack of Documentation- One of the key values of Agile Manifesto is “Working Software over Comprehensive Documentation”. This value would appear to be a direct contradiction of the regulatory requirements. The FDA regulations require a medical device software development organization to fully document requirements prior to development. In terms of achieving regulatory compliance, documentation is significant and as such it would still be produced when following agile practices. 5) Based on these preliminary searches, has the focus of your research changed? In what way? Based on my preliminary searches, the focus of my research has NOT changed. During reviewing the articles couple with my personal experience in the medical device domain, specifically medical device software development, I have realized that the use of agile methods for developing medical device incorporating software in regulated GRAD 695 TOPIC REFINEMENT ASSIGNMENT NOV 2017 2
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environments has not yet been demonstrated enough, and this topic being new, very little rigorous research exists in this area. Some of the essential characteristics of agile approaches appear to be incompatible with the constraints imposed by regulated environments. Identifying those areas and researching about the ways agile approach can be implemented successfully in FDA regulated industry would be interesting.
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  • Summer '18
  • Christopher Plummer

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