PubMed文献
PubMed / NCBIの医療機器関連文献
Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.
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続きを読む →Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.
続きを読む →Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.
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続きを読む →Networked Radiology Imaging and Treatment Planning Systems and FDA Cybersecurity Regulation: A Difference-in-Differences Analysis of 510(k) Clearance Delays.
続きを読む →Sensitivity of 510(k) medical device filings to government shutdowns: a brief communication.
続きを読む →Public transparency and physicochemical standardization in the regulation of PMMA dermal fillers: a comparative analysis of FDA, EU MDR, and ANVISA frameworks.
続きを読む →Clinical Specialty Expansion of AI-Enabled and Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration From 1995 to 2025: Longitudinal Content Analysis.
続きを読む →Deployer-side governance of medical imaging artificial intelligence: the regulatory readiness instrument (RRI-MI) for multi-jurisdictional and post-market compliance.
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