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Endigest AI Core Summary
Modern software as medical devices (SaMD) are now cloud-native composite systems where regulatory compliance has become automated and evidence-based through Compliance as Code patterns.
•FDA QMSR alignment with ISO 13485:2016 and EU AI Act require automated audit trails, change control, and data governance for AI-enabled medical devices
•Compliance as Code implements controls programmatically, with evidence generated continuously during system operation rather than through manual reviews
•Three-plane architecture model: data plane handles encryption and integrity, control plane enforces Zero Trust and Identity Aware Proxy, evidence plane captures immutable audit trails and binary authorization
•Cloud infrastructure enables superior risk management through shared fate model with cryptographically signed attestations and automated policy enforcement
This summary was automatically generated by AI based on the original article and may not be fully accurate.
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