Faculty
Tony Chan
- Total Product Life Cycle and Enterprise Risk Management Specialist
- Senior Advisor to WG03 Quality Management System of the Asian
Harmonization Working Party
- Advisor to the Global Harmonization Task Force
- U.S. Co- Chair for the ISO/TC210
- JWG1 on Medical Device Risk Management
- Advisor to FDA CDRH Medical Device HACCP Program and
Technical Expert on Dependability Management of the IEC TC56.
Alfred Dolan
- Professor Emeritus of Clinical Engineering at the University of Toronto
- Convener of the Joint IEC/ISO Working Group on Application of Risk Management to Medical Devices
- Member of numerous medical risk management and standardization advisory boards
Brian Donato
- Director in the law firm of Hyman, Phelps & McNamara, LLC
- Extensive experience in providing legal counsel relating to the Federal Food Drug and Cosmetic Act, FDA regulations, and state-specific food/drug laws and regulations.
George Flick, Jr.
- University Distinguished Professor (Virginia Tech)
- Fellow of the American Association for the Advancement of Science
- Member of the Seafood HACCP Alliance Steering Committee, and the Global Risk Management Alliance.
Stan Mastrangelo
- Quality Assurance professional with over 27 years of industry management experience
- Experienced expert member of the ANSI Executive Standards Council, ISO/IEC 14971 Risk Management for Medical Devices, PhRMA team for ICH Q9 Pharmaceutical Risk Management, and other ISO and IEC International Committees.
Joseph Salyer
- Environmental Health Specialist
- Captain, U.S. Public Health Service, currently assigned to the Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration.
- Training Coordinator for the Global Risk Management Alliance
Juergen Stettin
- Current chair of Clinical Engineering at the University of Applied Sciences in Hamburg, Germany
- Major research activities in the fields of telemedicine, medical software, and risk management.
