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
ISO17664:2017 provides guidance on this issue and states that “At least one validated automated cleaning method (which may include a validated manual cleaning method as part of the automated cleaning validation) shall be specified unless the medical device cannot withstand...
Learn from the industry-leading experts at Nelson Laboratories in the three-day webinar series Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes including FDA, ISO, USP, and MDRs. The experts at Nelson Labs are teaming with MD+DI to...
With their flexibility and complex components, endoscopes present unique cleaning and disinfecting challenges. Endoscope manufacturers, regulatory bodies, and healthcare facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. The concern over...
Every year Nelson Laboratories tests and validates thousands of medical devices. One particular family of reusable medical devices, endoscopes, can present unique challenges for manufacturers and healthcare reprocessing facilities. Responding to recent attention on reusable endoscopes, particularly the reusable duodenoscopes...
The FDA’s new guidance document, Reprocessing Guidance for Industry and FDA Staff issued March 17, 2015, outlines a summary of changes to the FDA’s May 11, 2011 reprocessing draft guidance. Based on the content and addition of Appendix E, this...
