A Sneak Preview of FDA’s Human Factors Standard
For nearly two decades, the Association for the Advancement of Medical Instrumentation’s (AAMI) human factors standard, HE 48, has been the only existing medical device user interface design standard.
With increased emphasis by global regulatory agencies on eliminating and controlling use error in devices, a new human factors standard with more direct relationship to healthcare contexts has been developed by the AAMI Human Factors Standards Committee. In this article, Pat Patterson and Robert North offer a preview into the new standard and how it applies to manufacturers.
Read the article: http://www.mddionline.com/article/sneak-preview-fdas-human-factors-standard
Tags: capa, fda, guidance, human factors
