Latest posts
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Global Approach to Software as a Medical Device
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What are examples of Software as a Medical Device?
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Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
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Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
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Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles
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EU AI Act
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AI Airlock: The Regulatory Sandbox for AIaMD
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Characterization Considerations for Medical Device Software and Software-Specific Risk
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Good machine learning practice for medical device development: Guiding principles
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South Africa’s Artificial Intelligence Planning