Medical Devices 2012 - Design History Files, Device Master Records, Device History Records, and Technical Files / Design Dossiers -- Differences and Similarities

This webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs -- their commonalities and their differences.
Why Should You Attend:
Global companies must meet different product design documentation for the U.S. and the European Union / Common Market. 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 File or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF may soon borrow some features required in the TF/DD. Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both. What are DMRs and DHRs relationship to DHFs, TF/DDs?
Areas Covered in the Seminar:
- The U.S. FDA's DHF.
- The EU's MDD and the Technical File / Design Dossier.
- Design Control 'Over Time' vs. a Product 'Snapshot in Time'.
- DHF "Typical" Contents.
- TF / DD Expected Contents.
- Parallel Approaches to Documentation -- Teams.
- The DMR and DHR.
- Some Future Trends to Consider.
- FDA and NB Audit Focus.