The FDA Medical Device File (DHF, DMR, DHR, Market Authorizations) and EU MDR Technical Documentation

Description

One of our most popular webinars, updated with the latest FDA and EU requirements. As U.S. companies go global, they must meet different product design documentation, but with key similarities  The cGMP's mandate Design Control and the Design History File (DHF). These terms are changed under the new QMSR.  In order to sell globally, the EU requires the CE mark, a QMS, and a Technical File.  These have different names that their US FDA counterparts, but they have many similarities. Under harmonization, the TF/D is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/D. And there are other FDA required documents that are virtually identical in purpose and in content.  How / where do the DMR and DHR fit?   Being aware of the similarities and differences can further concurrent development and/or updates to both.

This webinar will…