FDA Regulatory Science Lecture: Systems Engineering to Develop Safe and Effective Products
Thursday, October 31, 2013
Room 2116 Chemical and Nuclear Engineering Bldg.
Professor Keith E. Herold
Systems Engineering to Develop Safe and Effective Products
Division of Electronics and Software Engineering
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health
About the Speaker
Sandy Weininger received his BSEE and MS/BME from Drexel University focusing on the properties of the electrode-tissue interface and his Ph.D. in Bioengineering from the University of Pennsylvania where he specialized in signal processing and control systems. He worked for Carter-Wallace, Inc., in Cranbury, NJ where he was responsible for setting up and developing their biosensor research program. He moved to the US FDA/Center for Devices and Radiological Health where he worked with a team of engineers to design and develop the Apnea Monitor Performance Standard and supporting test methods and was the principal engineer and developer for NIH Fox trial recording system. Currently, Dr. Weininger is a senior engineer with the Division of Electronics and Software Engineering of the Office of Science and Engineering Laboratories within the FDA's Center for Devices and Radiological Health. Dr. Weininger's areas of concentration are design and engineering of electronics and signal processing systems as applied to small physiological signals. His responsibilities include supporting the regulatory process with technical consults, leading industry-government partnership efforts to develop consensus standards, performing forensic engineering analyses, and developing test methods. Dr. Weininger's current focus is performance assessment of sensors and actuators and assuring the safety of interoperable systems. He is member of ASTMs F29 Devices in the Integrated Clinical Environment committee, chair of the ASTM Pulse Oximeter Committee, and FDAs liaison to IEC TC 62 and SC 62A, committees responsible for safety of electromedical equipment. He is supporting the Secretarys Advisory Committee on Heritable Disorders in Newborns and Children studying the use of pulse oximetry in newborn screening.