Mr. Charles H. Kyper , Kyper & Associates LLC

208 Barrington Overlook Dr.
Durham, NC 27703
Phone: (919) 598-8666
Fax: (919) 598-8667

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Profile:
Since 1994 Mr. Charles Kyper has extensive experience as a consultant and successful expert witness in litigation involving devices such as latex gloves; spinal implants; embolization devices; coronary stents, ablation devices; automated external defibrillators, fetal vacuum extractors, and pacemaker leads. He is a recognized expert on FDA device labeling requirements and authored peer-reviewed articles on a wide range of device-related subjects. Mr. Kyper represents both plaintiffs and defendants based upon the merits of the case.

During his 28-year FDA career he was a field office investigator and headquarters compliance officer. He initiated the Office of Small Manufacturers Assistance in the FDA Center for Devices and Radiological Health (CDRH) and oversaw the scientific, regulatory and administrative review of Premarket Approval Applications.

Education/Licenses:
B.S. Biology

Years as Expert: 6

Primary Area of Expertise: FDA Medical Device Regulation