Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration 2015

Key Topics

• Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to DHF, DMR, and DHR
• Brief introduction to Lean Documents and Lean Configuration
• Device Master Records (DMR) content, development, and management
• Design History Files (DHF) content, development, and management
• Applying lean principles to creating, developing, and managing a DHF
• Device History Record (DHR) content, development, and management
• Applying lean principles to creating, developing, and managing DHRs
• Applying lean principles to creating, developing, and managing a DMR

Who should Attend

• R&D
• Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
• Design Assurance
• Manufacturing Engineering
• Operations
• Quality Assurance
• Document Control