FREE ON-DEMAND WEBINAR
Design Controls are a set of quality practices and procedures which govern medical device design.
They are promulgated in 21 CFR 820.30 of the Quality System Regulation and are intended to ensure that user needs and intended uses are met and that finished devices are safe and effective for their intended use.
An effective Design Control system connects key Quality Management Subsystems and impacts not only pre-market design and development, but also impacts post market device management.
This webinar will begin with a brief overview of Design Controls followed by the 5 key QMS subsystems that when connected to the Design Control process create an effective audit proof Design Control system. You will also discover the roll that these key connections play in post market vigilance activities and the one “must have” tool to aid in the process.