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
For three decades, the ISO 10993 international standard series has provided the overarching guidance on evaluating medical devices for biocompatibility. The new international standard, ISO 18562, addresses gaps. Here’s what you need to know. Read the Full Story in Medical Design...
When validating the steam sterilization instructions for a reusable medical device, first-time pass rates are important to manufacturers. Failures in validation testing require resolution, adding to the total validation time, which can result in a delay to regulatory submission, getting...
Robert Haley, Packaging Department Manager, Nelson Labs The American Society for Testing and Materials International (ASTM) Committee Meeting for F02 and D10 committees was recently held in Lansing, Michigan. During the F02 meeting, there were discussions for potential round robin...
