Contact this Expert Witness
- Company: The Silverman Group
- Phone: (301) 213-5780
- Cell: (301) 213-5780
- Website: silverman-group.com
Specialties & Experience of this Expert Witness
General Specialties:
Medical Devices and Pharmaceutical RegulationSpecialty Focus:
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 systemEducation:
JD, University of Pennsylvania Carey Law School; BA, University of MichiganYears in Practice:
25+Additional Information
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, engaged Congress and the press, and guided the office’s reorganization. Steve’s FDA experience includes positions as Assistant Director in the Center for Drugs, Office of Compliance, and Associate Chief Counsel, Office of the Chief Counsel. Adding to these are past positions with the US Department of Justice and the Federal Trade Commission.