The U.S. FDA's DHF
The EU's MDD and the Technical File / Design Dossier
Design Control vs. a Product 'Snapshot in Time'
DHF "Typical" Contents
TF / DD Expected Contents
Parallel Approaches to Documentation -- Teams
Future Directions
FDA and NB Audit Focus
The EU's MDD and the Technical File / Design Dossier
Design Control vs. a Product 'Snapshot in Time'
DHF "Typical" Contents
TF / DD Expected Contents
Parallel Approaches to Documentation -- Teams
Future Directions
FDA and NB Audit Focus
