PubMed 문헌
PubMed / NCBI의 의료기기 관련 문헌
Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.
더 읽기 →Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.
더 읽기 →Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.
더 읽기 →Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.
더 읽기 →Regulating cell and xeno-transplants: Learning from medical device oversight.
더 읽기 →Artificial Intelligence in Indian Dermatology: An IADVL Academy Position Statement and Policy Framework for Safe, Equitable, and Effective Adoption.
더 읽기 →Networked Radiology Imaging and Treatment Planning Systems and FDA Cybersecurity Regulation: A Difference-in-Differences Analysis of 510(k) Clearance Delays.
더 읽기 →Sensitivity of 510(k) medical device filings to government shutdowns: a brief communication.
더 읽기 →Public transparency and physicochemical standardization in the regulation of PMMA dermal fillers: a comparative analysis of FDA, EU MDR, and ANVISA frameworks.
더 읽기 →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.
더 읽기 →Deployer-side governance of medical imaging artificial intelligence: the regulatory readiness instrument (RRI-MI) for multi-jurisdictional and post-market compliance.
더 읽기 →일치하는 논문이 없습니다.
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