Alan P. Schwartz President/Founder, mdi Consultants, Inc.

A recognized international expert in US FDA regulations and quality system implementation. A former US FDA Supervisor of field operations and has been consulting to the FDA regulated industries, medical devices, pharmaceuticals, foods and cosmetics. With over 52 years of regulatory experience. Provided expert testimony, domestically and internationally, involving FDA compliance, drug and device failure, as well as regulatory issues. Been an invited speaker on the FDA policy and issues both in the US and internationally. Have written numerous articles and white papers on FDA issues. He provides his expertise on the FDA regulatory issues and policies to the medical device industry worldwide with clients in Thailand, Malaysia, Japan, Korea, China, Taiwan, Europe, Colombia, Argentina, Brazil and Canada.

BS Biology