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
Written by our experts, our blog provides updates on regulatory issues, upcoming changes to compendial test standards, and information about our participation with standard writing committees and organizations (AAMI, ASTM, AATB, ISO).
FDA released the long-awaited guidance document for international standard ISO 10993-1 this week. The guidance document represents the current thinking...
With their flexibility and complex components, endoscopes present unique cleaning and disinfecting challenges. Endoscope manufacturers, regulatory bodies, and healthcare facilities...
