Applying ISO/IEC 29110 to ISO/IEC 62304 for Medical Device Software SME

2019 ◽  
Author(s):  
Natsuda Kasisopha ◽  
Panita Meananeatra
Keyword(s):  
Medical Device ◽  
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

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.

scholarly journals Model-Based Engineering for Medical-Device Software

2010 ◽  
Vol 44 (6) ◽  
pp. 507-518 ◽  
Author(s):  
Arnab Ray ◽  
Raoul Jetley ◽  
Paul L. Jones ◽  
Yi Zhang
Keyword(s):  
Software Architecture ◽  
Formal Verification ◽  
Medical Device ◽  
Infusion Pump ◽  
Design Information ◽  
Safety Requirements ◽  
Model Based ◽  
Medical Device Software ◽  
Efficient Construction ◽  
Design Techniques

Abstract This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software.1

Sign in / Sign up

Export Citation Format

Share Document