Published Date: November 27, 2020
Reprocessing validations of Reusable medical devices have seen overlooked for quite some time. With the MDR requirements and US FDA Scrutiny over reusable medical devices has shed a light to their importance and significance. The presentation will highlight some of the key aspects of what is required for cleaning validation studies, the first step in the reprocessing cycle.
Pharmaceuticals and Microbiology Expert
Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe in 2013 as Study Director Extractables & Leachables, focusing on parenteral applications, and in 2014, she became responsible for the chemical characterization testing of medical devices (ISO 10993-18). In 2016,...
