Design Change Analysis Four Considerations 2014 is a webinar that covers topics such as:
- 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
Design Change Analysis Four Considerations 2014 brings together:
- Engineering Managers
- Regulatory Managers
- Quality Managers
- Design Engineers
- Project Managers
- Quality Engineers
- UDI Coordinators
- UDI Regulatory Contacts
