Mr. Stiegman manages and directs the clinical and regulatory affairs departments for MCRA and its clients. Mr. Stiegman is responsible for management of approximately 15 clinical and regulatory professionals at MCRA. Mr. Stiegman leads the firm’s submission process, regulatory strategy, analysis and development: from pre-clinical testing, to FDA submissions, to market approval and post commercialization. He also oversees the planning and execution of the clinical studies managed by MCRA’s Clinical Research Organization.
Prior to joining MCRA in February 2006, Mr. Stiegman served as the Chief of the Orthopedic Devices Branch for US Food and Drug Administration. As Branch Chief, Mr. Stiegman managed a team of scientists, clinicians, and engineers in the regulation of all orthopedic devices marketed in the United States. In addition, Mr. Stiegman was responsible for overseeing all FDA guidance documents and FDA policy determinations for orthopedic devices marketed in the US. Furthermore, he assisted in and oversaw all integrity, compliance, and monitoring issues regarding the orthopedic industry in collaboration with the Office of Compliance.