Roundtable on Good Manufacturing Practice for Medical Devices

Sponsored by the U.S. Embassy, Seoul, the U.S. Department of Commerce, The Advanced Medical Device Industry Association (AdvaMed) The American Chamber of Commerce in Korea
March 30, 2006

Selected Presentations:

1. Introduction to KFDA's GMP Plans (pdf)— KFDA Representative
2. Quality Systems — An Overview (pdf)— John Stigi, U.S. FDA
3. Requirements for Importing Medical Devices into the U.S. (pdf)— John Stigi, U.S. FDA
4. Role of Design Controls in Quality Systems (pdf)— Carolyn Albertson, Abbott Laboratories
5. Value of Technology (pdf)— Nancy Travis, AdvaMed
6. Product Testing in Safety Certification (pdf)— Fred Halverson, Medtronic, Inc.