Problem Statement Assignment_Vishakha Wadnerkar.docx

Users needs thus negatively affecting the growth of

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user’s needs thus negatively affecting the growth of the product . (Consequence). Perhaps research that investigates cases of successfully implemented Agile models and methodologies in Medical device development could remedy this situation. Resources that Support this Problem Statement (Provide two of your best resources including links) ing_Medical_Device_Software.pdf 4d.pdf GRAD 695 Problem Statement Assignment Nov 2017 Clear Focused Specific Arguable
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My Problem Statement/ Question On the surface these highly iterative, non-linear agile methods, which emphasize rapid execution over careful planning and documentation, seem antithetical to FDA-mandated design controls. However, that’s partly because of a misperception of regulations and standards—even though they are generally presented in a linear, waterfall style, that doesn’t mean they have to be implemented that way. And, if properly implemented, agile methods can actually enhance compliance for product development. Because agile
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  • Summer '18
  • Christopher Plummer
  • Iterative and incremental development

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