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PubMed-Literatur

Publikationen zu Medizinprodukten aus PubMed / NCBI

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.

Zeitschrift Computational and structural biotechnology journal

Datum 2025-07-15

PubMed

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

Zeitschrift JMIR medical informatics

Datum 2025-07-11

PubMed

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

Zeitschrift Expert review of medical devices

Datum 2025-07-06

PubMed

Assessing the Impact of End-of-Life Processing on Reusable Medical Devices.

Zeitschrift Biomedical instrumentation & technology

Datum 2025-06-11

PubMed

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

Zeitschrift PLOS digital health

Datum 2025-06-05

PubMed

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

Zeitschrift Annales pharmaceutiques francaises

Datum 2025-06-04

PubMed

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

Zeitschrift PloS one

Datum 2025-05-30

PubMed

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

Zeitschrift Expert review of medical devices

Datum 2025-05-29

PubMed

Eine umfassende Übersicht über reale-world-Evidenz in der Zulassung von medizinischen Geräten in den Vereinigten Staaten.

Zeitschrift Expert review of medical devices

Datum 2025-05-28

PubMed

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

Zeitschrift Cureus

Datum 2025-05-21

PubMed

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

Zeitschrift Cureus

Datum 2025-05-20

PubMed

Genauigkeit und Sicherheit eines kontinuierlichen nichtinvasiven Blutdruckmessgeräts bei Neugeborenen.

Zeitschrift Neonatology

Datum 2025-05-19

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