The BioMedTech SIG mission is to engage the regulatory, industry, and academic communities with honest, informed, advanced discussion of biomedical and biotechnical research and topics as relating to quality principles and practices, to the professional advancement, intellectual development, and personal growth of our members, to camaraderie within our community, and to public service.

U.S.  Food & Drug Administration: Food; Drugs; Medical Devices; Biologics, Blood, & Vaccines; Cosmetics; Radiation-Emitting Products; Combination Products

Biotechnology & Biomedicine: Medicine, Bioinformatics, Pharmacogenomics, Pharmaceutical Products, Medical Devices, Genetics & Testing, Biological Engineering, Bioengineering

Biomedical Auditing & Quality Control: Quality Assurance, Quality Control, Quality & Lean Six Sigma Applications

Dr. George Chang

Dr. George Chang is a veterinarian, pathologist, pharmacologist, self-trained analytical chemist, and board-certified toxicologist with extensive working knowledge and hands-on experience conducting in vitro and in vivo pre-clinical efficacy and safety research.  He has successfully managed regulated, pre-clinical safety projects and programs and assisted construction of a world-class toxicogenomic databases within the past decade.  Currently, Dr. Chang is leading a team of M.S. scientists/project managers with specialty in regulatory affairs, quality assurance, or quality control and responsible to launch and conduct regulated clinical trials, strategically prepare and submit critical regulatory documents, and interact and negotiate with regulatory agencies for candidate drugs under development.  His career goals are to evaluate and manage testing programs to assess efficacy and safety of biomedical products/devices and to facilitate collaboration within and provide related information to/for scientific communities.

Mr. Daniel Moone

Mr. Daniel Moone has over thirty years of experience and accomplishments covering the entire project development lifecycle and has extensive knowledge of FDA regulations, quality systems, medical device design and development, computerized system validation and qualification, software project management, compliance auditing, and software quality assurance and control.  Mr. Moone currently acts as Senior Software Quality Assurance Engineer for Boston Scientific.  Before joining Boston Scientific, he provided software engineering, quality assurance, and technical leadership services to Eli Lilly, Medtronic, CardioDynamics, Endocardial Solutions, IBM, GE Aerospace, and AT&T.  His body of work includes 510(k) IDE submissions and applications for pharmaceutical manufacturing, cardiac rhythm management, aircraft stall protection, hemodynamic monitoring, hemodialysis, heart imaging, diesel engine diagnostics, air-to-ground communication, manufacturing quality assurance, database management, communications satellite control, and aircraft engine controls.  He holds a B.S. degree in Computer Science from the University of Maryland and is a member of the Association for the Advancement of Medical Instrumentation (AAMI), the Association for Computing Machinery (ACM), and the Institute of Electrical and Electronics Engineers (IEEE).  He also holds a seat on the board of directors for Habitat for Humanity, Manassas and Manassas Park.

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.  The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.