Steve Silverman is the Director of CDRH’s Office of Compliance. In this role, he oversees a staff of more than 180 scientific and regulatory personnel who assure compliance with the medical-device related provisions of the federal Food, Drug, and Cosmetic Act and its implementing regulations.
May 6 - 9, 2014
Dr. Thomas J. Fogarty is an internationally recognized cardiovascular surgeon, inventor, entrepreneur, and vintner. He has been involved with a wide spectrum of innovations in business and technology.
Paul has worked with BSI since 1981, and is now responsible for leading BSI activities in the medical devices regulatory sector including EU Notified Body, EU/US Conformity Assessment Body, Health Canada / SCC CMDCAS accreditation and US FDA recognition.
Jay Crowley is currently Vice President and Practice Lead for UDI at USDM, a leading global professional services firm focused exclusively on providing business process, technology and compliance solutions for the regulated life science industry.
Christy Foreman is currently the Director of the Office of Device Evaluation (ODE). Before being named to the Director position, she served as the Deputy Director for Science and Regulatory policy in ODE.
Jeffrey E. Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009.
Monica joined Abbott in 2007 and provides strategic support and technical expertise to the medical device Divisions within Abbott. Prior to joining Abbott, Monica worked for the Food and Drug Administration (FDA).
Patrick is Director, Product Surveillance, GE Healthcare, where he is responsible for the company’s global post market surveillance and associated quality systems.
MedCon brings the global Medical Device community together to openly discuss the most pressing issues facing our industry. You have the opportunity to influence decisions and have your voice heard, as you interact with leading FDA officials and field investigators along with global industry experts.Learn More
Join us for the evening event on Thursday evening of MedCon. It will be held at Great American Ball Park which serves as the home of the Cincinnati Reds, baseball’s first professional franchise.
Rep. Erik Paulsen (R-Minn.) said he talked with Speaker John Boehner (R-Ohio) this week to discuss legislation that would repeal the medical device tax in ObamaCare.