Dr. Robert North is a regulatory-affairs focused human factors consultant specializing in the application of methods and analysis techniques for the management and control of medical device use related hazards, and usability measurement, particularly as applied to the FDA pre-market device approval process and international usability standards compliance.
He has consulted with over 200 companies regarding the implementation and documentation of medical device usability and use safety. From 2009 to 2016, he was the faculty lead of the Association for the Advancement of Medical Instrumentation's (AAMI) three day human factors short course. He is also a member of AAMI's Human Factors Standards Committee recently involved in creating and revising current human factors standards and guidances for industry.