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    Guides · AI/ML

    AI/ML guides.

    Every guide we've published on AI/ML.

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    6 guides tagged AI/ML

    AI/ML article cover: AAMI CR34971 Explained: AI Risk Management for Medical Devices
    AI/MLReference

    AAMI CR34971 Explained: AI Risk Management for Medical Devices

    What CR34971 adds on top of ISO 14971, the AI-specific risk categories it covers, and how to integrate it with your existing risk file.

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    Cover image for EU AI Act vs FDA AI/ML Cybersecurity for Medical Devices and SaMD
    AI/MLReference

    EU AI Act vs FDA AI/ML Cybersecurity for Medical Devices and SaMD

    How EU AI Act Article 15 cybersecurity obligations for high-risk AI compare to the FDA's PCCP framework and Section 524B applied to AI/ML SaMD - model integrity, adversarial robustness, postmarket monitoring.

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    AI/ML article cover: FDA 2025 AI-Enabled Device Software Functions Guidance, Decoded
    AI/MLReference

    FDA 2025 AI-Enabled Device Software Functions Guidance, Decoded

    Plain-English breakdown of FDA's 2025 draft AI guidance: what it adds beyond PCCP and GMLP, transparency labeling expectations, and what reviewers want to see.

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    Cover image for FDA PCCP: Predetermined Change Control Plans for AI/ML Medical Devices
    AI/MLReference

    FDA PCCP: Predetermined Change Control Plans for AI/ML Medical Devices

    How to author a Predetermined Change Control Plan (PCCP) that clears FDA review - modifications protocol, methods, impact assessment, and cybersecurity coverage under the 2024 final PCCP guidance and the February 2026 premarket cybersecurity guidance.

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    AI/ML article cover: GMLP Crosswalk: 10 Principles to Engineering Controls
    AI/MLReference

    GMLP Crosswalk: 10 Principles to Engineering Controls

    Each of the FDA/Health Canada/MHRA Good Machine Learning Practice principles mapped to concrete engineering, QMS, and documentation controls.

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    Cover image for PCCP Template & Worked Example for AI/ML Medical Devices
    AI/MLPlaybook

    PCCP Template & Worked Example for AI/ML Medical Devices

    How to write a Predetermined Change Control Plan FDA will accept - structure, the three required components, performance bounds, and a worked example.

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