Edwin Bills is a member of ISO TC 210 JWG1 which has updated ISO 14971 risk management standard for medical devices to the third or 2019 edition, along with the Technical Report ISO TR 24971:2019 which is now in its second edition. He has published several articles, including "Documenting Medical Device Risk Management throuogh the Risk Traceability Summary" in AAMI's Spring 2015 Horizons supplement to Biomedical Instrumentation and Technology publication. He also authored a risk management chapter in the recent, Combination Products: Implementation of cGMP Requirements, Ed's latest publication is Lifecycle Risk Management for Healthcare Products from Research Through Disposal available at www.pda.org. He has assisted a number of medical device and combination products companies in development, training, and implementation of product risk management systems. Mr. Bills has presented product risk management programs in the United States and internationally.