Medicines and Healthcare products Regulatory Agency; U.S. Food and Drug Administration; Health Canada Archives - AI Standards Hub

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Content Type

Medicines and Healthcare products Regulatory Agency; U.S. Food and Drug Administration; Health Canada

Frameworks and principles

Predetermined change control plans for machine learning-enabled medical devices: Guiding principles

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Topic:

Risk management Safety

Domain:

Healthcare and medicine

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In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles…

Organisation: Medicines and Healthcare products Regulatory Agency; U.S. Food and Drug Administration; Health Canada

Last Updated: 23 Jan 2024

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