The U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs covers topics such as:
- 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
The U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs intended for attendees from departments like:
- Research and Development
- Quality Assurance
- Manufacturing
- Regulatory Affairs
- Operations
- Engineering
- Supplements
- Production
- Documentation
- Marketing