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Live Webinar: "Design Change Analysis: Five Steps to Compliance"

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
  • Start:August 27, 2021
  • End:August 28, 2021
  • Recurring
  • Where:New York, New York,, Not found, Not found, Not found, 10018
  • Phone:N/A
  • Event Type: Other
  • Ticket Price:N/A
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