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Stephen Weber Consulting LLC

Screenshot 2026-06-27 8.09.53 AM
Screenshot 2026-06-27 8.09.53 AM

About

Thirty-five years experience as practicing orthopedic surgeon with four years as CDRH FDA Medical Officer and six years as independent regulatory consultant covering a wide range of device and biologic applications.

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Extensive experience with Breakthrough Applications, PMA, and De Novo as well as IDE development. Also cover EU MDR CER evaluations and medical publication as well as Independent Safety Monitor for ongoing IDEs.