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’s guidance on reprocessing re-usable medical devices[1] indicates that in addition to reprocessing instructions that allow for thorough cleaning, an...
