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:
- 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
- Regulatory