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USFDA Guidance: Predetermined Change Control Plans (PCCPs) for AI/ML Medical Devices
Artificial Intelligence and Machine Learning (AI/ML) are increasingly used in medical devices—from diagnostic imaging software to digital...

Sharan Murugan
Aug 192 min read
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USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...

Sharan Murugan
Mar 30, 20231 min read
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