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PUBLISHED ARTICLE

ISO Chemical Characterization for Medical Devices

Published In: Medical Device and Diagnostics Industry (MD+DI)

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.

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Nathan Fredrick

Nathan Fredrick

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...