Member of FDA's Hospital Bed Safety Workgroup, presentations on Hospital Bed Safety including checking compliance of beds with FDA standards.

During his career in medical device manufacturing, Mr. Bills has held a number of quality and regulatory affairs positions including a recent period as Corporate Director of Risk Management. He has over 20 years experience in the field of quality and regulatory affairs. Mr. Bills served as Director of Quality Systems and Regulatory Affairs, responsible for FDA compliance and pre-market submissions for multiple US locations of a major medical device manufacturer. He also served as the Corporate Director of Risk Management. Mr. Bills has served as a member of the FDA Hospital Bed Safety Workgroup since its founding in 1999.

Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices. In this position he represented the United States on the ISO/IEC Joint Working Group on risk management for medical devices, the group responsible for authoring ISO 14971 the medical device risk management standard. He also served as the liaison between ISO TC 194 Sterilization Standards and IEC SC 62 Medical Device Electrical standards. Mr. Bills has presented courses for the American Association of Medical Instrumentation (AAMI) and the Advanced Medical Technology Association (AdvaMed), and as guest lecturer at the University of Southern California graduate program in Regulatory Affairs.

Currently he is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management. Working as a consultant, Mr. Bills has assisted major medical device manufacturers improve their risk management processes to comply with regulatory requirements and international standards. He has also assisted with the development and improvement of design, development, manufacturing and service processes and preparation of pre-market submissions for manufacturers in the medical device industry. Mr. Bills has also provided expert services to legal counsel in the area of risk management and FDA compliance.

Bilanx Consulting LLC requests payment of travel expenses.