March 20, 2015
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for Industry and FDA Staff issued March 17, 2015, outlines a summary of changes to the FDA’s May 11, 2011 reprocessing draft guidance.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...
See BlogMay 14, 2014
On April 14-16, 2014, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers,...
See BlogFebruary 6, 2014
Agenda: Emily Mitzel will present on reusable medical device cleaning, disinfection and sterilization validations at the 2014 MD&M West Conference. Emily is a Laboratory Manager at Nelson Laboratories in Salt Lake City, Utah. Her presentation will include: Standards that govern...
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