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.
FDA QSR §820.30(i) spells out the basics of design change but is only the starting place for you and your team.
InDesign Change Analysis: Five Steps to Compliance — Dan O’Leary — an industry expert with more than 30 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
Keep all the moving parts of design change in sync with Design Change Analysis, which lays out the factors you must consider along with the decisions you must make.
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About the Author
Dan O’Leary is president of Ombu Enterprises LLC, a company offering training and execution in operational excellence focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has 30+ years’ experience in quality, operations, and program management in regulated industries including medical devices and clinical labs. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Who Will Benefit
Regulatory Affairs Professionals
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