FDA approval expert witnesses analyze how drugs, devices, and biologics move through the regulatory pathway from preclinical data to postmarket surveillance. They are often former FDA reviewers, regulatory affairs professionals, clinical researchers, or industry executives who assess compliance with guidance, study design, labeling, risk management, and quality systems.
Medical Device Product Development Expert Witness
Medical Device Product Development Expert Witness
- Review Fee
- $600/hr
- Deposition Fee
- $600/hr
- Court Fee
- $600/hr
This expert has experience in Medical devices since 1992. Design experience since 1986. Areas of expertise include full life cycle product development of medical devices from conception through development including manufacturing, bench testing, verification, validation, packaging, labeling, clinical trials, regulatory approval, marketing, and sales training. Granted 28 patents (others pending), 7 awards, designs published by Life Magazine, was recognized as one of 100 notable people in the medical device industry by the Medical Device & Diagnostic Industry (MD&DI) publication in June 2008. This expert recently served as chairman of the Medical Device & Manufacturing Conference in 2014.
President, A medical device development consultancy in NH
Master of Science (MS), North Carolina A&T State University
Dover,
New Hampshire