Edwin Bills Edwin Bills Consultant

During his over 35-year career in quality and regulatory affairs in medical devices, Edwin L Bills has held a number of positions with major manufacturers including an assignment as Corporate Director of Risk Management. He also served as Director of Quality and Regulatory Affairs with responsibilities for FDA compliance and for pre-market submissions at multiple locations. For over 24 years, Mr. Bills has acted as a United States representative on ISO TC 210 JWG1, the author of ISO 14971, the international standard for medical device risk management and is also a member of AAMI Committee CP on Combination Products. Mr. Bills presently consults in Quality Systems and Risk Management for medical devices and combination products and provides expert witness support. Throughout his career he has been adjunct faculty for courses in risk management and quality systems including the graduate health product risk management program at Virginia Tech. Currently he also teaches college courses at Pathways for Patient Health and consults and provides training in the area of medical device quality systems, regulatory affairs and risk management.