February 2006, Mr. Stiegman served as the Chief of the Orthopedic Devices Branch for US Food and Drug Administration.
Mr. Stiegman holds a Bachelor of Science degree in Biomedical Engineering from Tulane University. He also received a Masters degree in Bioengineering from Clemson University.
Mr. Stiegman was the team leader on many state-of-the-art spinal technologies; managed a team of scientists, clinicians, and engineers in the regulation of all orthopedic devices marketed in the United States. He has led or participated in a number of FDA Advisory panel meetings leading many clients to a positive panel outcome and ultimate PMA approval. Mr. Stiegman has successfully written and managed a number of first of a kind orthopedic and spine PMAs, De Novo 510(k)s, and high profile 510(k)s.
Overview
Mr. Stiegman manages and directs the clinical and regulatory affairs departments for MCRA and its clients. Mr. Stiegman is responsible for management of >125 clinical and regulatory professionals at MCRA.
Mr. Stiegman leads the firm's:
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Regulatory
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Regulatory Strategy and Technology Positioning
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Regulatory Submission Development
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FDA Interaction and Negotiations
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Data Analysis and Development
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Pre-clinical Testing Review and Analysis
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Clinical Protocol Development
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Rescue 510(k)s, De Novo, and PMAs
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Market Labeling and Compliance
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Post Commercialization Compliance
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International Registrations
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Clinical Evaluation Reports
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Clinical
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Study Set-up
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Site Identification
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Site and Contract Negotiations
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Study Management
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Clinical Events Committee
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Monitoring
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Study Close-out
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Data Management
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Data Analysis Programming
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