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
Many good things are happening within our Healthcare Processing Team at our facility in Leuven, Belgium (GLP certified and ISO17025 accredited). Over the past year, we’ve experienced a notable uptick in test requests from medical device manufacturers. This surge has...
Nelson Labs Europe is pleased to announce that we have recently expanded our ISO17025 accreditation for our healthcare reprocessing services. Reusable medical devices must be properly cleaned, disinfected, and/or sterilized. One of the services that Nelson Labs offers is to...
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...
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...
