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AI/ML-Enabled Medical Devices — 4 Keys To Obtain Global Regulatory Approval Artificial intelligence (AI) and machine learning (ML) are disrupting and improving our world. With intelligent machines capable of high-level cognitive processes like thinking, perceiving, learning, problem-solving, and decision-making, coupled with advances in data collection and aggregation, analytics, and computer processing power, AI and ML present opportunities to complement and supplement human intelligence. Application of AI and ML in medical devices is making possible AI/ML-driven diagnostics and personalized treatments. Artificial intelligence has the potential to provide incremental value to medical device designers and manufacturers and is expected to be the key source of competitive advantage for firms that adopt it. Global regulators have understood that AI and ML models do not fit well within the current medical device regulatory framework and are feverishly working to achieve a harmoniz

John giantsidisSoftware risk managementCyberacta incInformation technologyInternational medical device regulators forumArtificial intelligenceSystems using machine learningRisk managementமென்பொருள் ஆபத்து மேலாண்மைதகவல் தொழில்நுட்பம்சர்வதேச மருத்துவ சாதனம் கட்டுப்பாட்டாளர்கள் மன்றம்செயற்கை உளவுத்துறைஅமைப்புகள் பயன்படுத்தி இயந்திரம் கற்றல்ஆபத்து மேலாண்மை