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
The reusable medical device industry has advanced over the last decade, which has led to an increase in new reusable devices. New devices require extensive testing that must be reviewed by the Food and Drug Administration (FDA) or other regulatory...
Reusable medical device manufacturers should provide users with a method or mechanism to determine when a device has exceeded its intended use life, or they should specify a number of times it can be reused. Guidance documents stipulate that manufacturers...
