FDA Inspection Issue Terminology

FDA issues Field Management Directives on a number of subjects including #120 483s and #86Estabilishment Inspection Report Conclusions and Decisions. The latter is at the link provided and includes tables definings FDA’s terminology for rating inspectional issues and conclusion.

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IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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