Kristy Katzenmeyer-Pleuss, Ph.D. is a Senior Medical Research Manager for NAMSA, a medical device CRO providing full-service support throughout the product development process. Kristy was previously based in the U.S. with NAMSA’s regulatory team and is currently based in Berlin, Germany with NAMSA’s EU regulatory, quality, validation, and biosafety team. Kristy’s role is to help clients with U.S. regulatory strategy, premarket submissions and responses to additional information requests, global regulatory research, developing and reviewing protocols and reports for reprocessing and sterilization validations as well as chemical and biological testing, and preparing biological risk assessments.
Kristy is a former U.S. FDA lead medical device reviewer; her experience includes premarket submissions for a variety of device types, including general surgical, dermatologic, cardiovascular, peripheral venous, oncologic, orthopedic, and aesthetic devices.
While at the FDA, Kristy also served as a subject matter expert in the areas of biocompatibility, reprocessing (reusable and reprocessed single-use devices), and sterilization. She was actively involved in medical device policy development, including drafting Guidance documents, new classification regulations, and proposed Orders/Rules. Kristy also participated in manufacturing site inspections to provide scientific/technical support to FDA’s district and national field officers.
Kristy holds a Ph.D. in Bioengineering from the University of Washington and a B.S. in Chemical Engineering from the University of Wisconsin-Madison.