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
