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FEATURED BUNDLE

Medical Device AI (US)

For US medical device manufacturers shipping AI/ML-enabled devices. Covers FDA quality system requirements, AI-enabled device software guidance, and predetermined change control plans.

4 frameworks included · $200 per check

Frameworks in this bundle

A single check evaluates your document against every framework below.

21 CFR Part 820 — Quality System Regulation (Medical Devices)

FDA regulation for medical device quality systems. Applies to AI/ML-enabled medical devices including software as a medical device (SaMD).

FDA Guidance — AI-Enabled Device Software Functions

FDA guidance on regulatory approach to AI/ML-based software as medical device (SaMD) and device software functions.

FDA Guidance — Predetermined Change Control Plans for AI/ML Devices

FDA guidance for manufacturers of AI/ML-enabled devices on predetermined change control plans allowing iterative model updates.

NIST AI 100-1 — AI Risk Management Framework (AI RMF 1.0)

Comprehensive framework for managing risks in AI systems across the lifecycle. Core functions: Govern, Map, Measure, Manage.

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