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Request Free AssessmentAI-enabled medical devices are medical devices integrated with AI algorithms for clinical decision support, diagnosis, or treatment planning. Under the EU AI Act, these are generally classified as high-risk AI systems, requiring compliance with standards like ISO 42001 and ISO 14121. Risk-adjusted implementation is essential for regulatory approval and market access.
Curated by Winners Consulting Services Co., Ltd.
Winners Consulting helps organizations turn this concept into workable policies, processes and audit readiness.
Need help with compliance implementation?
Request Free Assessment