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Podcast: Beyond Clean Podcast
Episode: Don Tumminelli: The Unknown World of Medical Device Validation
Description: There are many questions and often a critical level of misunderstanding about medical device validation so on this re-released throwback episode from Season 2, we went right to the source and interviewed validation expert Don Tumminelli, Senior Technical Manager, Client Services at HIGHPOWER Validation Testing and Lab Services. When a manufacturer designs a medical device, specifically a Class II device that requires 510K clearance by the FDA, they need an IFU that outlines how the device is to be safely cleaned and sterilized. Listen to Don talk about biocompatibility testing (compatible with the human body), sterilization validation and cleaning validation...