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
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...
Nelson Labs reusable devices expert Alpa Patel recently discussed regulatory changes and what they could mean for cleaning validations of new devices, validations of legacy devices, and studies conducted prior to recent standard updates. Read the full Q&A article published...
Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Additionally, many validation testing requirements were formulated using generalities rather than...
Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Only general recommendations were formulated, which resulted in one validation approach...
Dialysis machines have been used for decades to help improve the lives of people with kidney malfunctions. Developed in the 1930s, these machines have evolved to ensure the delivery of lifesaving solutions to patients who suffer from kidney complications. The...
