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 Association for the Advancement of Medical Instrumentation (AAMI) recently released the first cleaning validation standard for medical device manufactures, ANSI/AAMI ST98:2022 Cleaning validation of healthcare products—Requirements for development and validation of a cleaning process for medical devices. This new standard that...
Reusable medical devices need to have validated cleaning instructions to ensure patient safety and minimize health-care-acquired infections, corrective actions, recalls, and to ensure compliance with current regulatory standards. For devices that need to comply with US FDA, the requirements regarding...
