Gretchen Upton joined QA Consulting as a Regulatory and Quality Consultant in 2019. Gretchen specializes in creating and maintaining quality systems, gaining clearance for device applications in various divisions (orthopedic, software decision support), and creating and maintaining CE mark documents (technical files/documentation), Clinical Evaluation Reports (CER).
Gretchen is a QA/RA/Clinical Research professional with over seventeen years’ experience in medical device development and clinical research trials while working with Menninger Clinic, The Cleveland Clinic, BioMedical Enterprises (DePuy Synthes), and Dascena.
She currently serves on both the Texas Medical Device Alliance (TMDA) committee and FDA Medical Device Industry Coalition (FMDIC).
Gretchen also served on U.S. Chamber of Commerce Americas Business Dialogue Regulatory Affairs Working Group 4 team, which supported medical device business development opportunities within Latin American markets.
Gretchen holds a Bachelor’s degree from Kansas State University, Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society (RAPS), Certified Quality Auditor (CQA) certification from the American Society for Quality (ASQ), and is a Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates (SOCRA).