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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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Príomhchruthaitheoirí: Max Ostermann, Rebecca Mathias, Fatemeh Jahed, Mitchell B. Parker, Florence D. Hudson, William C. Harding, Stephen Gilbert, Oscar Freyer
Formáid: Artigo
Teanga:Inglês
Foilsithe / Cruthaithe: Elsevier 2025-01-01
Sraith:Computational and Structural Biotechnology Journal
Ábhair:
Rochtain ar líne:http://www.sciencedirect.com/science/article/pii/S2001037025002892
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