Donna Hartzfeld

Donna Hartzfeld, Ph.D., is an accomplished professional with extensive experience in quality assurance and compliance consulting within the medical device and pharmaceutical industries. Since 1999, Donna has served as President and Owner of Quality Implementation Services, Inc. Additionally, Donna holds positions as a Senior Compliance Consultant at NDA Partners LLC and Senior Consultant at IQVIA. Previous roles include Compliance Consultant at LumiraDx, Quality Engineer Consultant for Natus Medical Incorporated, and Senior Quality Assurance Consultant at NSF International. With a strong educational background including a Ph.D. in Chemistry from Arizona State University and a BA in Chemistry and Biology from the University of North Carolina at Greensboro, Donna has expertise in FDA compliance, ISO standards, and design controls for various medical devices and combination products.