The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
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...
The following poster was presented at the extractables & leachables session of the annual conference of American Society for Mass Spectrometry (ASMS) in Minneapolis. Read the following abstract to learn more: Medical device testing is a significant part of a...
The following poster was presented at the extractables & leachables session of the annual conference of American Society for Mass Spectrometry (ASMS) in Minneapolis. Read the following abstract to learn more: Medical device testing is a significant part of a...
Thor Rollins, consulting manager, and Audrey Turley, research scientist, have been invited to speak at the joint conference of the Association of Analytical Communities Southern California Section (AOAC SCS) and Food and Drug Agency (FDA) 2016 Spring Conference. Rollins and...
The landscape of biocompatibility assessment of medical devices is an ever-changing and evolving one. Recently, there has been a lot of effort put into the development of alternatives to in vivo biocompatibility testing. Expanding technological capability and increased scientific understanding...