Medical device design change is a demanding and uneasy process. Failure to dot all your i’s and cross all your t’s can lead to inspection problems and missed market opportunities.
In Design Change Analysis: Five Steps to Compliance — our expert with more than 20 years of experience in quality, operations and program management — presents a comprehensive plan for creating a robust design change procedure, including discussion of the primary FDA regulations and ISO standards governing design change, as well as flowcharts and decision-making tools to walk you through the five steps to compliance:
How production and process changes impact design change
When a design change requires a new device identifier to be assigned
Whether the change requires submission of a new 510(k)
Whether the change will require a correction or removal of devices from the field
Whether changes need to be made to the device’s risk management file