U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
12 May 2022
Webinar
Key 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
Past Events
U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs - 12 May 2022, Webinar (82269)
U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs 2026
Important
Please, check "U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Medical device, Pharma
Science: Biochemistry, Chemistry, Laboratories, Life Sciences & Biology
