The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software

  title={The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software},
  author={Hossein Mehrfard and Abdelwahab Hamou-Lhadj},
  journal={Int. J. Inf. Syst. Model. Des.},
The difficulty of complying with different regulations has become more evident as a large number of regulated businesses are mandated to follow an ever-increasing set of regulations. These regulations often drive significant changes in the way organizations operate to deliver value to their customers. This paper focuses on the impact of the Food and Drug Administration FDA regulations on agile software development processes, which in many ways can be considered as just another type of… Expand
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