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PubMed

Integrating artificial intelligence into medical device quality systems and health-care practice.

PMID: 42968549 ·

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JournalExpert review of medical devices
Year
PMID42968549

Abstract

Quality Control (QC) and Quality Assurance (QA) are central to safety, effectiveness, and regulatory compliance of medical devices. The transition from 21 CFR 820 to the Quality Management System Regulation (QMSR) formalizes harmonization with ISO 13485. Artificial intelligence (AI) is being explored in clinical and manufacturing settings and may support medical-device quality and compliance when appropriately validated. This review examines AI applications within QC, QA, and regulatory systems

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