scholarly journals Barriers to Adopting Agile Practices When Developing Medical Device Software

2012 ◽  
pp. 141-147 ◽  
Author(s):  
Martin McHugh ◽  
Fergal McCaffery ◽  
Valentine Casey
Keyword(s):  
Medical Device ◽  
Medical Device Software ◽  
Agile Practices

scholarly journals A Hybrid Fuzzy Rule-Based Multi-Criteria Framework for Security Assessment of Medical Device Software

2020 ◽  
Vol 13 (5) ◽  
pp. 51-62
Author(s):  
Abdullah Algarni ◽  
◽  
Masood Ahmad ◽  
Abdulaziz Attaallah ◽  
Alka Agrawal ◽  
...  
Keyword(s):  
Medical Device ◽  
Fuzzy Rule ◽  
Security Assessment ◽  
Rule Based ◽  
Medical Device Software

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

2011 ◽  
Vol 2 (2) ◽  
pp. 67-81 ◽  
Author(s):  
Hossein Mehrfard ◽  
Abdelwahab Hamou-Lhadj
Keyword(s):  
Medical Device ◽  
Software Process ◽  
Regulatory Compliance ◽  
Extreme Programming ◽  
Organizational Processes ◽  
Medical Device Software ◽  
Development Processes ◽  
Agile Software ◽  
The Impact ◽  
Fda Regulations

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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