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 meet different product design documentation. The U.S. FDA's CGMPs mandate Design Control and the Design History File (DHF) at 21 CFR 820.30. In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical FiIe or Design Dossier, as described in their Medical Device Directive. What are the requirements for each file. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. And how / where do the DMR and DHR fit? Being aware of the required content, as well as the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.
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