ABSTRACT
This chapter is aimed at introducing Design Control requirements while attempting to show that good understanding of such regulations is no insurance to designing safe and effective medical devices. Design Control requirements, part of the Food and Drug Administration’s (FDA’s) Quality System Regulations (QSRs), went into effect on June 1, 1998. Before this period, medical device companies selling their products in Europe had been required to comply with the Design Control requirements of ISO 9001and the EN 46001 standards. Design Control is one of the four major subsystems in the Quality System Regulations.*
What is Design Control?
