Center for Professional Innovation & Education (CfPIE), Berlin, Germany
Sep. 10 & 11, 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.
|
|