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

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

Hossein Mehrfard, Abdelwahab Hamou-Lhadj
Copyright: © 2011 |Volume: 2 |Issue: 2 |Pages: 15
ISSN: 1947-8186|EISSN: 1947-8194|EISBN13: 9781613507605|DOI: 10.4018/jismd.2011040104
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MLA

Mehrfard, Hossein, and Abdelwahab Hamou-Lhadj. "The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software." IJISMD vol.2, no.2 2011: pp.67-81. http://doi.org/10.4018/jismd.2011040104

APA

Mehrfard, H. & Hamou-Lhadj, A. (2011). The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software. International Journal of Information System Modeling and Design (IJISMD), 2(2), 67-81. http://doi.org/10.4018/jismd.2011040104

Chicago

Mehrfard, Hossein, and Abdelwahab Hamou-Lhadj. "The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software," International Journal of Information System Modeling and Design (IJISMD) 2, no.2: 67-81. http://doi.org/10.4018/jismd.2011040104

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Abstract

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 organizational processes. Particular focus is placed on the ability for Extreme Programming (XP) to support FDA requirements. Findings show that XP fails to meet many of the FDA guidelines for medical device software, which increases the risks of non-compliance for organizations that have adopted XP as their main software process. The results of this study can lead the work towards designing an extension to XP for FDA regulations.

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