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List of Known Anomalies

Use this “List of Known Anomalies” template to document any unresolved software bugs or residual issues that will remain in the released version of your medical device software. Completing this is essential for compliance with IEC 62304, and it should be filled out before software release to ensure transparency and risk management for both regulatory submissions and internal quality assurance.

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List of Known Anomalies

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1. Scope

The list within this document identifies the residual anomalies or "bugs" that exist in the software that will not be corrected prior to the software release in this version.

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2. Known Residual Anomalies

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