Regulatory Issues and Medical Device Certification

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Years in this theme: All years 2024 2022 2021

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

2024

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

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

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

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2022

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

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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2021

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

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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