DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements 2014

Topics

• The Design History File - documenting Product Design Control and its nine elements
• The Design Control requirements of the CGMPs, 21 CFR 820.30
• The EU’s Medical Device Directive
• The Device Master Record and the Device History Record
• The remaining elements of a Technical File / Design Dossier
• The "Essential Requirements"; and their documentation
• Two attendee projects
• Trends

Who should Attend

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