FDA - AI based SaMD

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FDA - AI based SaMD
Data Governance (DG)
Technical Documentation (TD)
Transparency and Provision of Information to Users (TPI)
- TPI01 - Transparency of the AI System
- TPI02 - Instructions for Use
Human Oversight (HO)
Accuracy, Robustness and Cybersecurity (ARC)
Managing SaMD Lifecycle Support Process - Record Keeping (RK)
Risk Management System (RMS)
Quality Management Principles (QMP)
Post Market Monitoring System (PMS)

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Technical Documentation (TD)

TD19 - Reports Signed

All documents and test reports must be dated and signed by the responsible persons. A statement that all documents and test reports are signed and dated is required to be uploaded to Seclea Compliance.

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Last updated 2 years ago