Development and Application of Guidelines for Compliance with IEC 62304 International Standards for AI Medical Device Software

2021 ◽  
Vol 48 (1) ◽  
pp. 71-81
Author(s):  
DongYeop Kim ◽  
Ye-Seul Park ◽  
Byungjeong Lee ◽  
Jung-Won Lee
Keyword(s):  
Medical Device ◽  
International Standards ◽  
Medical Device Software

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

Neurosurgical materials and devices

1976 ◽  
Vol 45 (3) ◽  
pp. 251-258 ◽  
Author(s):  
Charles V. Burton ◽  
Joseph T. McFadden
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
International Standards ◽  
Current Status ◽  
Reference Source ◽  
Legal Authority ◽  
Content Type ◽  
Fine Print

✓ The current status of voluntary consensus standards writing procedures in neurosurgery and the current progress of government efforts to regulate materials and devices are described. A survey of the national and international standards writing bodies is presented, along with an introduction to related organizations and agencies and nomenclature. The intent of this review is to provide the neurosurgeon with a reference source regarding past and present neurosurgical activities in the materials and devices field. When President Ford signed the 1976 Medical Device Amendments on May 28, 1976, the Food and Drug Administration assumed direct legal authority to control medical devices and potentially assumed the power to regulate those professionals using them.

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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