Judi Smith

Background

About Judi Smith

Judi Smith, MS, MT (ASCP), is Vice President, Clinical/Regulatory at BioPorto Diagnostics Inc. Ms. Smith has worked in the medical products regulatory, quality, and clinical trial areas for over 30 years. In that time, she has been responsible for the regulatory submissions and approvals of a multitude of companion diagnostic assays, in vitro diagnostic products, and biological in vitro diagnostic assays, and for the establishment of quality systems for diagnostic products. She has also developed and implemented clinical trials for these products that were used to generate data for the regulatory submissions. She also is on the faculty of the RAPS University as an IVD Subject Matter Expert. As a member of the FDA/Industry Roundtable, Ms. Smith was awarded the FDA Group Recognition Award. She served as President of the Association of Medical Diagnostics Manufacturers for 10 years. This organization is dedicated to the in vitro diagnostic industry and provides educational programs with the FDA/CDRH/Office of In Vitro Diagnostics and Radiological Health. Ms. Smith received her Bachelor of Science from Temple University and her Master of Science from Medical College of Pennsylvania.