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EPA released a revised draft of OCSPP 810 Series Test Guidelines in June, now available for public review and comment. Accuratus Lab Services technical personnel have performed an initial review of the draft revisions. Read this summary of some of the significant proposed changes to each of the revised draft guidelines.
Reprocessing IFU Development and Validation Reusable medical device manufacturers are required by the U.S. Food and Drug Administration (FDA) to ensure all sets of cleaning instructions are validated and meet the parameters indicated on a device’s labeling. In light of 2015 news items on the use of potentially contaminated endoscopes in Los Angeles, Seattle and Philadelphia.
Obtaining the highest confidence that aseptic cleanrooms and other critical manufacturing/quality control (QC) environments are properly disinfected is paramount in assuring the production of safe and effective pharmaceutical products or medical devices.