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

@article{Mehrfard2011TheIO,
  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.},
  year={2011},
  volume={2},
  pages={67-81}
}
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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References

SHOWING 1-10 OF 35 REFERENCES
Investigating the Capability of Agile Processes to Support Life-Science Regulations: The Case of XP and FDA Regulations with a Focus on Human Factor Requirements
TLDR
It is shown how Extreme Programming, an agile process, lacks the necessary practices to support the stringent requirements of the FDA regulations for medical device software. Expand
Towards a compliance support framework for global software companies
Regulated companies are required to comply with the laws and regulations that apply to their industries. An important aspect of these authoritative rules is directly related to the way by whichExpand
FDA: Between Process and Product Evaluation
  • M. M. Abdeen, W. Kahl, T. Maibaum
  • Engineering
  • 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MDPnP 2007)
  • 2007
Several institutions and agencies around the world, from both the private and public sectors, have adopted the practice of software validation and certification to ensure higher levels of confidenceExpand
Exploring the Business Process Agility Issue: An Experience Report
TLDR
Through this study, the authors identified important requirements for the attainment of business process agility, which were subsequently combined into a holistic picture constituting a comprehensive suggestion for the practical realization ofbusiness process agility. Expand
Agile and Iterative Development: A Manager's Guide
Agile/iterative methods: From business case to successful implementationThis is the definitive guide for managers and students to agile and iterative development methods: what they are, how theyExpand
Why certification of medical software would be useful?
  • J. Forsström
  • Medicine
  • International journal of medical informatics
  • 1997
TLDR
Different aspects of evaluation of medical software are discussed, including quality assurance and regulation, which are essential to guide the users to use high quality services on the net. Expand
Assessing test-driven development at IBM
TLDR
A non-trivial software system based on a stable standard specification is built using a disciplined, rigorous unit testing and build approach based on the test-driven development (TDD) practice, which reduces the defect rate by about 50 percent. Expand
Software Engineering: A Practitioner's Approach with Bonus Chapter on Agile Development
Come with us to read a new book that is coming recently. Yeah, this is a new coming book that many people really want to read will you be one of them? Of course, you should be. It will not make youExpand
Traceability: Taming uncontrolled change in software development
TLDR
It is proved that there is a strong need for automated, integrated software development environments, where change propagation would be facilitated not only by humans, but also by software modules specifically dedicated to this task and spanning over all project artifacts. Expand
Integrating Software-Architecture-Centric Methods into Extreme Programming (XP)
TLDR
This report presents a summary of XP and examines the potential uses of the SEI's architecture-centric methods. Expand
...
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