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Cloud vs Infusion Pump
AI vs Handoff Strategy
Effects on healthsoftware of EU directive 2024/2853
Directive EU 2024/2853
AI Standards
Rule 11
Rule 11 vs MDCG 2019-11
Class I or not Class I that is the question
Is this really a Class I medical device?
Is segregation always necessary?
simplified software classification scheme according to MDR
MDSW intended for clinical scoring
Degree of autonomy vs Artificial Intelligence and Machine Learning
Reasonably foreseeable misuse and security