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
Equipment process validations are becoming one of the tissue banking industry’s most pressing regulatory compliance concerns. Until recently, the tissue industry has enjoyed a comparatively less regulated environment than medical device manufacturers and other medtech service providers. But a surge...
Department Scientist-Healthcare Reprocessing I recently attended the 10th Annual FDA and Changing Paradigm for HCT/P Regulation Conference, with my colleague Wendy Wangsgard, Department Scientist, Bioburden. We presented topics of interest that have surfaced the validation realm, in addition to learning...
