U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs

Topics

• The EU’s MDD / MDR and the Technical File / Design Dossier / Technical File
• The U.S. FDA’s 21 CFR 820.30 Design History File (DHF) and the ISO 13485:2016 Design and Development File
• Design Contol vs. a Product ‘Snapshot in Time’
• Device Classification U.S. FDA vs. EU MDD/MDR
• The DMR and DHR / Lot / Batch Record
• DHF "Typical" Contents
• Safety and Performance Rqmts
• TF / DD / TD Expected Contents, Essential or General
• Parallel Approaches to Documentation Teams
• Use Engineering File (IEC 62366-1, -2)
• FDA and NB Audit Focus

Who should Attend

Attendees from departments like:

• Research and Development
• Quality Assurance
• Manufacturing
• Regulatory Affairs
• Operations
• Engineering
• Supplements
• Production
• Documentation
• Marketing