Medical Devices and FDA Expert Witness

Medical Devices and FDA Expert Witness

Medical Devices and FDA | E-007962

Expert Qualifications

This highly qualified expert specializes in engineering and regulatory affairs for medical device commercialization. She earned a BS in mathematics from Oregon State University and a MS in Medical Device and Diagnostic Engineering from the University of Southern California. This expert currently owns and operates her own medical device company where she prepares and submits FDA regulatory services 510k applications.

Bio Snapshot

Location: California

BS, Mathematics, Oregon State University

MS, Medical Device and Diagnostic Engineering, University of Southern California

Certified Quality Auditor, American Society for Quality

Former, Sales and Account Manager, IBM Data Network

Former, Insulin Pump Sales, Medtronic Diabetes

Current, President, major surgical device corporation

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