AI in Healthcare

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regulationMedical Device and Diagnostic industry

FDA Regulatory Changes Could Reshape Device Compliance as QMSR and Human Factors Guidance Evolve

Two FDA policy updates are poised to affect device makers: changes tied to QMSR and adjustments to human factors guidance, including a new submission category. The combined effect could change how companies design, document, and file products for review.

FDAQMSRhuman factorsdevice regulation

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