Kristy Katzenmeyer-Pleuss

Speaking Session: Biocompatibility: It's More Complicated Than “We've Used Silicone Forever”

Kristy Katzenmeyer-Pleuss

President

KP Medical Device Consulting LLC

Dr. Katzenmeyer-Pleuss is the President of KP Medical Device Consulting LLC (KPMDC) and a former U.S. FDA medical device reviewer.  She has 15 years of experience in the regulated medical device industry and over 20 years in the broader biomaterials field, with a focus on U.S. FDA and EU medical device regulatory and biological safety requirements.  She is adept at helping medical device manufacturers navigate the overlap of these two fields. 

Prior to founding KPMDC, Dr. Katzenmeyer-Pleuss worked as a senior regulatory and biological safety consultant at NAMSA. While at the U.S. FDA, Dr. Katzenmeyer-Pleuss worked as a lead reviewer for pre-market submissions as well as a subject matter expert in biocompatibility, sterilization, and reprocessing of reusable devices. She drafted guidance documents and served on several working groups related to biocompatibility and reprocessing, collaborated with U.S. FDA’s internal laboratories on research projects vital to public health, and was selected as a technical expert for manufacturing site inspections. 

Dr. Katzenmeyer-Pleuss holds a Ph.D. in Bioengineering from the University of Washington and a B.S. in Chemical Engineering from the University of Wisconsin-Madison.