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
Thor Rollins, Michelle Lee, and Audrey Turley have been accepted as U.S. experts to four working groups in the Biological Evaluation ISO Technical Committee 194: WG5 (Cytotoxicity – Thor), WG8 (Sensitization and Irritation – Michelle), WG9 (Effects on blood – Michelle),...
As anticipated, the United States Food and Drug Administration (US FDA) issued a new guidance document on the use of ISO 10993-1 on June 16, 2016. In one statement the FDA summarizes how they want to see biocompatibility for medical...
FDA released the long-awaited guidance document for international standard ISO 10993-1 this week. The guidance document represents the current thinking of FDA on the topic of ISO 10993-1 “Biological evaluation of medical devices – Part I: Evaluation and testing within...
With their flexibility and complex components, endoscopes present unique cleaning and disinfecting challenges. Endoscope manufacturers, regulatory bodies, and healthcare facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. The concern over...
March is Women’s History Month and a great opportunity to spotlight the Women in STEM Education (WISE) committee at Nelson Laboratories, Inc. The WISE committee is comprised of 17 women scientists and leaders at the company who are passionate about...
