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Classification vs Reasonably foreseeable misuse

MDCG 2019-11 Table 1

What changes with MDCG 2025-4?

MDCG 2019-11 Rev 1: more and more confusion?

Cybersecurity and good practices

PATRIOT MISSILE DEFENSE

Intended use and identification of characteristics related to the security of the medical device

Class I or not Class I

Does Class III SaMD exist ?

𝗪𝗵𝗮𝘁 𝗮𝗿𝗲 𝘁𝗵𝗲 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿'𝘀 𝗹𝗶𝗺𝗶𝘁𝘀 𝗶𝗻 𝗲𝘀𝘁𝗮𝗯𝗹𝗶𝘀𝗵𝗶𝗻𝗴 𝘁𝗵𝗲 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗽𝘂𝗿𝗽𝗼𝘀𝗲𝘀 𝗼𝗳 𝗮 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲?

Device End of Life and Compensating Controls

AI vs Cybersecurity

NIS2 vs Medical device

CMS 8000 backdoor