Regulatory Issues and Medical Device Certification

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

Download Citation: END BibTex RIS

Challenges and Alternatives to Evaluation Methods and Regulation Approaches for Medical Apps as Mobile Medical Devices: International and Multidisciplinary Focus Group Discussion

Laura Maaß, Robert Hrynyschyn, Martin Lange, Alexandra Löwe, Kathrin Burdenski, Kaley Butten, Sebastian Vorberg, Mariam Hachem, Aldo Gorga, Vittorio Grieco, Vincenzo Restivo, Giuseppe Vella, Marlien Varnfield, Felix Holl

J Med Internet Res 2024 (Sep 30); 26:e54814

Download Citation: END BibTex RIS

Exploring Impediments Imposed by the Medical Device Regulation EU 2017/745 on Software as a Medical Device

Liga Svempe

JMIR Med Inform 2024 (Sep 05); 12:e58080

Download Citation: END BibTex RIS

Forecasting Artificial Intelligence Trends in Health Care: Systematic International Patent Analysis

Stan Benjamens, Pranavsingh Dhunnoo, Márton Görög, Bertalan Mesko

JMIR AI 2023 (May 26); 2:e47283

Download Citation: END BibTex RIS

Technology-Enabled, Evidence-Driven, and Patient-Centered: The Way Forward for Regulating Software as a Medical Device

Jane Elizabeth Carolan, John McGonigle, Andrea Dennis, Paula Lorgelly, Amitava Banerjee

JMIR Med Inform 2022 (Jan 27); 10(1):e34038

Download Citation: END BibTex RIS

Tracking the Presence of Software as a Medical Device in US Food and Drug Administration Databases: Retrospective Data Analysis

Aaron Ceross, Jeroen Bergmann

JMIR Biomed Eng 2021 (Nov 03); 6(4):e20652

Download Citation: END BibTex RIS