Steve Silverman

Steve Silverman 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 product quality and compliance, pre-market approval, and device advertising and promotion. Adding to this, Steve was a Senior Expert with McKinsey & Co., where he counseled pharmaceutical, medical device, and other clients on regulatory strategies, product compliance and quality, and stakeholder communication.

Steve’s professional experience includes nearly two decades in federal service, with extensive time in senior FDA roles. At FDA, Steve directed the CDRH Office of Compliance, where he led device-quality initiatives, engaged Congress and the press, and guided the office’s reorganization. Steve’s FDA roles include Assistant Director, CDER Office of Compliance, where he oversaw implementation of drug regulations, policy, and public communications about prescription and over the counter drugs. Steve
began his FDA work as an Associate Chief Counsel, where he led enforcement actions against drug and medical device companies. Steve’s past work includes positions with the US Department of Justice and the Federal Trade Commission.