Post-deployment monitoring and safety reporting of AI medical imaging devices in clinical practice

2026

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AI-generated summary

This guidance provides essential recommendations for ensuring the safe and effective use of AI medical imaging devices in clinical practice.

* Details recommended monitoring activities for clinical providers after deploying AI imaging solutions.
* Offers practical, step-by-step guidance on conducting post-deployment monitoring and safety reporting.
* Includes case studies and appendices with practical tools, such as supplier questions and audit protocols.

AI, medical imaging, post-deployment monitoring, safety reporting, clinical practice

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