Amy Hoffmann is a technical specialist with North American Science Associates Inc., or NAMSA (www.namsa.com), the world's foremost independent organization involved with evaluating the safety of medical devices.
NAMSA, founded in 1967, has been a leading, global medical-device contract research organization, specializing in the safety evaluation of Class I, II and III medical devices, as well as device and packaging materials, and drug/device combination products. In fact, NAMSA started testing medical devices pharmaceutical containers for safety before the U.S. Food and Drug Administration starting regulating such products in 1976. In addition to having four
Hoffmann joined NAMSA as a technical specialist in 2004 and now is transitioning to a role as product manager of chemistry and analytical services.
In her previous role as a technical specialist, Hoffmann supported NAMSA's
The holder of a B.S. degree in biochemistry from the University of Cincinnati, she has, in conjunction with Dr. Dave Albert, published technical papers on topics such as chemical equivalency and risk assessment, and she has also presented at national conferences on topics such as "Forming a Biological Safety Evaluation Plan" and “The Chemical Characterization of Materials as Change Control."
Before joining NAMSA, Hoffmann spent five years working as a research chemist focusing on the use amphipathic polymers to maintain activity in membrane enzymes and as a delivery system for membrane proteins. She was also involved in the development of other high-purity detergents for the medical research community.