Glenn Stiegman, M.S.

Glenn Stiegman, M.S.

Senior Vice President, Clinical & Regulatory Affairs

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.


  • 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:
    • Regulatory
      • Regulatory Strategy and Technology Positioning
      • Regulatory Submission Development 
      • FDA Interaction and Negotiations 
      • Data Analysis and Development 
      • Pre-clinical testing Review and Analysis
      • Clinical Protocol Development 
      • Rescue 510(k)s, De Novo, and PMAs
      • Market Labeling and Compliance
      • Post Commercialization Compliance
      • International Registrations 
      • Clinical Evaluation Reports
    • Clinical
      • Study Set-up
      • Site Identification
      • Site and Contract Negotiations 
      • Study Management
      • Clinical Events Committee
      • Monitoring
      • Study Close-out 
      • Data Management
      • Data Analysis Programming

Get in Touch