The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: August 12, 2020 from 8am to 2pm
Location: Online event
Street: Online event
Website or Map: https://www.gcplearning.com/v…
Event Type: online, event
Organized By: Globalcompliancepanel
Latest Activity: Jul 17
One of our most popular seminars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier under the old MDD, and the Technical Documentation requirements of the new MDR. Currently they serve differnt purposes, support different goals, but the TD File is moving in the direction of the DHF.
And the DHF is adapting to some of the features of the TDFile. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.