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Expert Bio

Primary Area of Expertise

FDA Regulatory Affairs

Expert Witness Profile

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 45 years of regulatory experience. Been involved with various cases of provided expert testimony involving FDA compliance, drug and device failure, as well as regulatory issues. Mr. Schwartz has been an invited speaker on the FDA policy and issues both in the US and internationally. He provides his expertise on the FDA to the medical device industry worldwide with clients in Japan, Korea, China, Taiwan, Germany, Italy, Argentina, Brazil and Canada. He also has a widely read Insight Report on dealing with the FDA, Mr. Schwartz also is an Internationally Certified Lead assessor for the ISO13485 and is on the editorial advisory board of the Institute of Validation Technology.

Education & Licenses

BS Biology