About this White Paper
The development of medical products is regulated by the US Food and Drug Administration, whose regulations permeate all aspects of development. In spite of some beliefs to the contrary, FDA rules and Agile development can coexist without any difficulty. This paper addresses common issues with FDA regulation, especially around requirements management and traceability of test cases.
Dr. Kevin Thompson, Ph.D.
Principal Consultant specializing in Agile hardware development. Dr. Thompson has guided more than 100 enterprise transformations, bridging the gap between hardware engineering and Agile software methodologies. About Dr. Thompson →