During his career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions for major medical device companies, including a period as Corporate Director of Risk Management. He has over 36 years’ experience in the field of quality and regulatory affairs, including time as Director of Quality and Regulatory concurrently for four US sites. Currently he consults and provides training in the area of medical device quality, regulatory and risk management. With Stan Mastrangelo, he co-authored Lifecycle Risk Management for Healthcare Products: From Research Through Disposal published by PDA. Mr. Bills was also a member of the adjunct faculty serving Virginia Tech’s graduate on-line degree program in Health Products Risk Management. ASQ has awarded Mr. Bills with Fellow status as well as Certified Quality Engineer, Certified Quality Auditor, Certified Manager of Quality and Organizational Excellence, and he is a Regulatory Affairs Certified by the Regulatory Affairs Professionals Society. Additionally, Mr. Bills serves in international standards work, assisted in completing the revision of the third edition of ISO 14971 risk management standard as an international member of the technical committee. He also serves on the US national committee for the medical devices quality system standard, ISO 13485 and the AAMI technical committee CP, developing a combination products risk management guidance.