Defective Medical Device Expert Witnesses in Texas

This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality solutions and training to both small and large companies, and entrepreneurs. This expert has been invited to speak nationally, and has authored 6 publications in FDA regulatory and quality matters.

This highly qualified expert has over 15 years of experience specializing in the electro-mechanical systems in medical devices. Specifically, this expert specializes in oxygen concentrators, oxygen conserving devices, breathe detection, power circuit design, instrumentation, and sensing. He earned his BS in electrical engineering from Northwestern and his MBA from Kellogg Graduate School of Management and has his six sigma black belt certification. He has held several roles including VP of engineering at Joslyn Hi-Voltage, director of electrical engineering at Baxter Healthcare and director of device risk management at Hospira. This expert also served as the director of global respiratory engineering in the home medical equipment division of Invacare. Currently, this expert owns a consultancy focused on the medical device product development in TX.

This expert researches how people access and respond to safety and health risk information, examining the effectiveness of consumer product and industrial equipment warnings. He earned his Bachelor's degree in Mass Communication from Kansas State University and both his Master's and doctoral degrees in Communication Studies from the University of Kansas. He has published his scholarly findings on the effectiveness of product warning labels and the communication of risk. He currently serves as a full professor of Communication at a prominent Texas university.

This qualified expert of Hospital Procurement obtained his AA from Enterprise State Community College and his BS from Troy State University. He is a certified Pharmacy Technician, Licensed Practical Nurse, and an Emergency Medical Technician. He is a Member of The Association for Healthcare Resource and Materials Management and is Currently a Senior Sales Executive for a Healthcare/Medical Device Corporation.