scholarly journals Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review

2020 ◽  
Vol 8 ◽  
Author(s):  
Petra Marešová ◽  
Blanka Klímová ◽  
Jan Honegr ◽  
Kamil Kuča ◽  
Wan Nur Hidayah Ibrahim ◽  
...  
2013 ◽  
Vol 7 (2) ◽  
Author(s):  
Christopher Sweem ◽  
Stan Crossett ◽  
Lori Lucke

In this paper a method is presented for using value stream mapping for improving the development process of medical devices. Two examples are shown to demonstrate the utility of this approach.


2008 ◽  
Vol 18 (1) ◽  
pp. 1215-1230 ◽  
Author(s):  
David J. Jones ◽  
Melissa T. Masters

Author(s):  
Kamya Nagarajan ◽  
Arlindo Silva

AbstractWith increasing level of advancement and complexity in medical devices, there is a need for methodology, tools and techniques in practice to integrate Human Factors and Usability (HF/U) elements in design due to its increasing diversity of users and rapidly changing interface types. This paper proposes a methodology to develop a tailor-made HF/U design guidelines for medical device development with various sources and to develop heuristics for evaluation and score the product usability throughout the development process.


2012 ◽  
Vol 9 (5) ◽  
pp. 537-543 ◽  
Author(s):  
Isa CT Santos ◽  
G Scott Gazelle ◽  
Luís A Rocha ◽  
João Manuel RS Tavares

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