DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements 2014 is a seminar that covers topics such as:
- 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
DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements 2014 is intended for:
- 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