Donna-Bea Tillman, PhD, FRAPS

Headshot of Dr. Donna-Bea Tillman
Title:
Senior Consultant (Medical Devices), Biologics Consulting Group

Dr. Donna-Bea Tillman is a senior consultant at Biologics Consulting Group with 17 years of medical device regulatory experience at the US Food and Drug Administration, Center for Device and Radiological Health. She held numerous positions within FDA CDRH, culminating in her 2004 appointment to the position of Director of the Office of Device Evaluation, where she oversaw the medical device premarket review program for non-IVD devices. During her tenure at FDA, she played a pivotal role in the development of guidance documents, standards, and policy frameworks for medical device software and health IT.

In 2010 she joined Microsoft’s Health Solutions Group as the Director of Regulations and Policy, where she was responsible for obtaining the appropriate global premarket registrations and managing Microsoft’s postmarket safety programs. Donna-Bea received her B.S.E. in Engineering from Tulane University, her Ph.D. in Biomedical Engineering from the Johns Hopkins University, and her Master’s in Public Administration from the American University.