Understanding Top Management Responsibilities for Medical Device Quality Management Systems


1 hour and 30 minutes

Course Overview

This course is designed to efficiently focus on top management obligations relative to FDA’s Quality System Regulation and ISO 13485:2016. This course does not simply focus on the requirements of the regulation and standard but provides insight into the expectations of the framers of those documents through discussions of the preamble to the quality system regulation, and TC 210 guidance relative to ISO 13485:2016.



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