Overview:
This one-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to...
Overview:
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions....
Overview:
One of our most popular subjects, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must...
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