Module 14: Design Development and Certification of Medical Devices

17/11/2023

STED Life Cycle Maintenance

REMEMBER: The STED is a LIVING document

It needs to be MAINTAINEDand kept up to date as more information is gathered on the device during use, and if any updates/changes are made Do the changes affect the: • Risk Assessment? • Essential Principles?

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• Regulators can AUDIT the STED at anytime, either by regular PLANNED audit, or, an UNANNOUNCED audit • Periodic Safety Update Reports (PSURs) STED Life Cycle Maintenance

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The Organisation for Professionals in Regulatory Affairs

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