Fda Enforcement Expert Witnesses
Fda enforcement expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on fda enforcement. The fda enforcement expert witness listings on this page are typically from fields/areas of expertise such as: Medical Devices and Pharmaceutical Regulation.
Steven D Silverman The Silverman GroupSilver Spring, Maryland
Medical Devices, Pharmaceutical Regulation - FDA, FDA expert, FDA regulatory, FDA medical device, FDA medical product expert, FDA medical product regulation, FDA medical device regulation, FDA compliance, FDA medical product compliance, FDA medical device quality, FDA warning letter, FDA enforcement, FDA consent decree, FDA quality system
Steve Silverman is an FDA regulatory expert with more than a decade in FDA leadership roles, including as the Director of the Office of Compliance in the medical-device center. Steve focuses on areas including post-market regulation, regulatory compliance and enforcement, medical device quality, and building effective business-regulator relationships. Steve is the President of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. Before this, Steve worked as Vice President, Technology and Regulatory Affairs, with AdvaMed, the leading medical-device trade association. Steve focused there on device quality and compliance, pre-market approval, advertising and promotion, and combination products. Steve brings to these roles global consulting experience with McKinsey & Co. and a range of FDA leadership positions. At FDA, Steve directed the Center for Devices Office of Compliance, where he led device-quality initiatives, enga...