Design changes are an important part of any medical device manufacturer’s quality management system to bring improved devices to market and to fix problems with existing designs. The Quality System Regulation provides the basic requirements for design changes in 820.30(i). However, it does not provide specifics on the information needed to satisfy practical considerations and FDA Regulations. A detailed understanding of the changes you should consider will help you create the most compliant system.
This 90-minute webinar explains the five design changes factors that you need to implement. You will learn:
- Why FDA’s QSIT equates production and process changes with design changes. You will learn the reasoning and the tools to help you make the evaluation.
- How to evaluate a change to determine if it creates a new version or model that requires a new Device Identifier (DI). The definition is open and allows flexibility to help make good decisions.
- How to determine if the design change requires a new 510(k) based on the significance of the change using the current guidance document published in 1997.
- How to classify the change for reportability under Part 806, Corrections and Removals. If the change is reportable, FDA will classify it as a recall.
- How to relate the change to the ISO 14971:2007 Risk Management File and update the hazard analysis and risk control measures.