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

Topics

• The EU`s MDD and the Technical File / Design Dossier
• The U.S. FDA`s DHF
• DHF "Typical" Contents
• Design Control `Over Time` vs. a Product `Snapshot in Time`
• Parallel Approaches to Documentation -- Teams
• TF / DD Expected Contents
• Some Future Trends to Consider
• The DMR and DHR
• FDA and NB Audit Focus

Design History Files, Device Master Records, Device History Records, and Technical Files / Design Dossiers -- Differences and Similarities brings together personnel involved in CE-marking environments and the U.S. FDA-regulated including: Regulatory affairs, Senior management, Production, Quality Assurance and Engineering & R&D.