Regulatory Issues and Medical Device Certification

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

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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

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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

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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

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