Center for Professional Innovation & Education, Inc., King of Prussia, PA
Oct. 29 & 30, 2012
This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus is placed on basic regulation and the FDA’s supplemental guidelines. Among the topics to be discussed are: the context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control.
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