Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier 2014

Topics

• Required and desirable contents
• How to meet and document their differing requirements
• Similiarities and differences, and future convergences and trends
• Areas requiring frequent re-evaluation / update
• Typical Technical File or Design Dossier contents
• Typical DHF contents
• Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed
• The importance and usefulness of the "Essential Requirements"
• Where the Device Master Record / Device History Record "tie in"
• Parallel approaches to development
• Differing approaches to records audits by the U.S. FDA and an EU Notified Body

Who should Attend

• Middle management
• Senior management
• Engineering
• R&D
• QA / RA
• Software
• Operations
• Manufacturing
• CGMP instructors
• Consultants
• All personnel especially involved in device development, regulatory compliance and documentation