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

  • 12 May 2022
  • Webinar

Description

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

Past Events

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

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