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).
Cardiovascular medical devices undergo particulate matter testing because once implanted, contaminants left on these devices pose serious risks to patient...
With DuPont’s Tyvek transition looming, manufacturers should consider performing a packaging validation as part of their implementation strategy. Nelson Laboratories...