PubMed 문헌

PubMed

Cybersecurity requirements for medical devices in the EU and US - A comparison and gap analysis of the MDCG 2019-16 and FDA premarket cybersecurity guidance.

학술지 Computational and structural biotechnology journal

날짜 2025-07-15

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PubMed

Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning-Enabled Medical Device Recalls in the United States: Implications for Future Governance.

학술지 JMIR medical informatics

날짜 2025-07-11

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PubMed

Clinical trial design in FDA submissions for neuromodulation devices, 1960-2023: a systematic review and meta-analysis.

학술지 Expert review of medical devices

날짜 2025-07-06

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PubMed

재사용 가능한 의료 장비의 최종 처리에 미치는 영향 평가

학술지 Biomedical instrumentation & technology

날짜 2025-06-11

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PubMed

The illusion of safety: A report to the FDA on AI healthcare product approvals.

학술지 PLOS digital health

날짜 2025-06-05

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PubMed

[Regulatory requirements for software medical devices: Comparison between Europe, the United States, and Algeria].

학술지 Annales pharmaceutiques francaises

날짜 2025-06-04

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PubMed

Scoping review on regulation, implementation and postmarket surveillance of medical devices.

학술지 PloS one

날짜 2025-05-30

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PubMed

Evaluation of clinical data and regulatory submission characteristics for neuromodulation devices approved via the 510(k) pathway (1996-2024).

학술지 Expert review of medical devices

날짜 2025-05-29

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PubMed

미국에서 의료 장비 승인에 대한 실제 증거에 대한 종합적인 개요.

학술지 Expert review of medical devices

날짜 2025-05-28

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PubMed

Prescription Digital Therapeutics Research Across Clinical, Engagement, Regulatory, and Implementation Domains: A Bibliometric and Thematic Study.

학술지 Cureus

날짜 2025-05-21

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PubMed

Decoding FDA Labeling of Prescription Digital Therapeutics: A Cross-Sectional Regulatory Study.

학술지 Cureus

날짜 2025-05-20

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PubMed

신생아에서의 지속적인 비침습 혈압 모니터의 정확성 및 안전성

학술지 Neonatology

날짜 2025-05-19

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