Published In: Medical Device and Diagnostics Industry (MD+DI)
August 10, 2023
This article by Nathan Fredrick, chemical characterization expert at Nelson Labs, discusses how manufacturers can be sure that their devices are safe for use by evaluating the extractable chemical levels and by following the guidance of ISO 10993-17 and ISO 10993-18.
Learn more about the author below.
Toxicology Expert
Nathan Fredrick is a toxicologist with the Expert Advisory Services team at Nelson Labs, where he uses his background in chemistry and biology to evaluate extractables and leachables (E&L) through toxicological risk assessments. In addition to his E&L expertise, he also specializes in evaluating volatile organic compounds (VOCs) from gas pathway devices per the ISO 18562 series of standards. Prior to his time on the Expert Advisory Services team, he worked with the Antimicrobial and Filtrations department at Nelson Labs as a study director, overseeing filter sterilization validations. Nathan graduated from Black Hills State University with a bachelor’s degree in biology and another bachelor’s degree in chemistry. He is currently pursuing a master’s degree in pharmacology and toxicology from Michigan State University.
