is being presented by William R. Mandel, Directory of Technology, with Oasis Medical Solutions and airs on Wednesday, August 25th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Human factors study has become a key element for FDA scrutiny. It is also a challenging field because subjective perspectives are evaluated and used to create a quantitative analysis, which must be concrete and testable. Careful consideration and execution must be utilized in navigating this less-than-comfortable process.
This presentation explores the multidimensional aspects of human factors design and testing from initial conception to manufacturing, and how to compile the essential core human factors elements to add to the design history file. Understanding terminology is a key aspect of this process. The speaker also discusses the importance of risk analysis and its process in relation to human factors testing. Finally, we explore the fundamentals of performing human factors testing in a real-world scenario and examine the methods of turning data into concrete, acceptable, easy-to-understand documentation.
