Our whitepapers allow you to dig deeper into topics and understand the science behind our services, as well as ways we can help solve your business challenges.
By: Gregory Grams, Michael Padilla, Peter Strain, Thor Rollins The Current Regulatory Landscape for EO Residue Levels in Medical Devices: What Manufacturers Need To Know Now, and What May Be on the Horizon Ethylene oxide gas sterilization, in particular, is...
By Matthew R. Jorgensen, PhD, Thor Rollins, Martell Winters Download this whitepaper to learn about the various biocompatibility and sterilization considerations surrounding 3D-printed orthopedic devices. 3D-printed orthopedic medical devices are gaining attention and popularity due to their potential for enhanced...
By Erin Bakes, Alexa Tatarian Performing a cleaning validation during the initial phase of a device’s lifecycle aids manufacturers in complying with current good manufacturing practices (CGMP) and quality system (QS) regulation as set forth by FDA for medical device...
