Regulatory Issues and Medical Device Certification

Articles published in 2025 in this theme: 3 (scroll down to load remaining articles)

2025

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Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study

Marlen Peseke, Ilja Michaelis, Ornella Tangila Kayembe, Majella Geraghty, Ali McDonnell, Franco Luigi Zurlo, Zoe Sophie Oftring, Nicolas Martelli, Tom Melvin, Sebastian Kuhn

J Med Internet Res 2025 (Oct 01); 27:e77982

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Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification?

Alex Emilio Fischer, Samanta Tresha Lalla-Edward, Vinodh Edward, Musaed Abrahams, Luke Shankland, John de Wit

JMIR Mhealth Uhealth 2025 (Aug 22); 13:e60276

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

Wei-Pin Chen, Wei-Guang Teng, C Benson Kuo, Yu-Jui Yen, Jian-Yu Lian, Matthew Sing, Peng-Ting Chen

JMIR Med Inform 2025 (Jul 11); 13:e67552

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