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

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Authors: Max Ostermann, Rebecca Mathias, Fatemeh Jahed, Mitchell B. Parker, Florence D. Hudson, William C. Harding, Stephen Gilbert, Oscar Freyer

Journal title: Computational and Structural Biotechnology Journal

Journal number: 28

Journal publisher: Elsevier BV

Published year: 2025

DOI identifier: 10.1016/J.CSBJ.2025.07.024

ISSN: 2001-0370