Design Change Analysis – Four Considerations 2014

Key Topics

• The reason why FDA could consider a Production Change as a Design Change
• The relationship among Design Output, Design Transfer, and Production Control
• The triggers that create a new DI and to document your decision
• The elements of the new UDI rule including the Device Identifier (DI)
• Use of the 510(k) change guidance document to document your evaluation
• The requirement to evaluate change significance for 510(k) purposes
• Implications for FDA Inspections
• Changes to the Risk Management File as a result of a design change

Who should Attend

• Engineering Managers
• Regulatory Managers
• Quality Managers
• Design Engineers
• Project Managers
• Quality Engineers
• UDI Coordinators
• UDI Regulatory Contacts