The DHF, Technical File and Design Dossier - Similarities, Differences and the Future 2018

The DHF, Technical File and Design Dossier - Similarities, Differences and the Future 2018 is a seminar that provides knowledge on Medical Device documentation requirements and implementation, including:

• Device Master Records
• Device History Files
• Technical Files / Design Dossiers, documents, activities / plan(s)
• Device History Records

Topics covered:

• The Design History File - documenting Product Design Control and its nine elements
• The Design Control requirements of the CGMPs, 21 CFR 820.30
• Summary of morning discussion
• The Device Master Record and the Device History Record
• Review of group activity and Q&A
• Group activity on the 1) The DHF, or 2) The DMR and DHRs
• The "Essential Requirements" and their documentation
• The EU`s Medical Device Directive
• ISO 14971:2012, The Product Risk Management File / Report overview
• The remaining elements of a Technical File / Design Dossier
• DHF / TF, DD Trends
• Review of group activity and Q&A
• Group activity on 1) The Technical File / Design Dossier, or 2) Essential Requirements

Who should Attend

Attendees from medical device regulated companies, including:

• Regulatory Affairs
• Senior and middle management and staff
• R&D
• QA/QC
• Manufacturing Engineers
• Production Management
• Project Managers
• Process Engineers
• Anyone involved in medical device development, documentation, and regulatory responsibilities
• Vendors, sales and marketing