is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Thursday, September 16th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews several guidance documents issued by FDA regarding its human factors initiative. The speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
