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

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

The increasing use of connected medical devices has led to substantial cybersecurity challenges, putting patient safety and the integrity of healthcare infrastructures at risk. This study examines regulatory guidance on medical device cybersecurity in the European Union (guidance document of Medical...

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Bibliographic Details
Main Authors: Max Ostermann, Rebecca Mathias, Fatemeh Jahed, Mitchell B. Parker, Florence D. Hudson, William C. Harding, Stephen Gilbert, Oscar Freyer
Format: Article
Language:English
Published: Elsevier 2025-01-01
Series:Computational and Structural Biotechnology Journal
Subjects:
Medical devices
Cybersecurity
Regulatory science
Online Access:http://www.sciencedirect.com/science/article/pii/S2001037025002892
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