Krista Oakes - Senior Consultant, Regulatory Affairs

Since 1989, Krista Oakes has been involved in quality assurance and regulatory affairs in the medical device industry. Krista has worked with large and small manufacturers representing a broad spectrum of medical device technologies. Prior positions include Director of Quality Assurance and Regulatory Affairs for Quest Medical, Vice President of Regulatory Affairs and Quality Assurance for Epic Medical, President of Epic Medical, and Vice President - Medical Device Division for Shotwell & Carr.

Krista is an active participant in the medical device industry with memberships in the Regulatory Affairs Professionals Society (RAPS), the American Society for Quality (ASQ), and the Association for the Advancement of Medical Instrumentation (AAMI); and currently serves as the industry co-chair for the Dallas District FDA/Medical Device Industry Coalition. Krista has been an industry speaker and author of articles on practical and efficient approaches to quality systems.