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Taiwan FDA excels at international regulatory harmonization of medical devices

Taiwan FDA excels at international regulatory harmonization of medical devices
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FDA wants to require timely updates, patches for legacy devices: cyber chief

FDA wants to require timely updates, patches for legacy devices: cyber chief
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Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed | Butler Snow LLP

Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed | Butler Snow LLP
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Global Healthtech CEO Connect: Software As A Medical Device In The U.S. And EU Recap | MoFo Life Sciences

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On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at the end of the program.
Globally, the convergence of software technology and life sciences creates a massive opportunity for growth, and the market for these products is growing exponentially. Both the U.S. Food and Drug Administration (FDA) and European regulators have focused on establishing a regulatory framework for oversight of SaMD. ....

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AIML-Enabled Medical Devices — 4 Keys To Obtain Global Regulatory Approval

AI/ML-Enabled Medical Devices â 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 ....

John Giantsidis , Software Risk Management , Cyberacta Inc , Information Technology , International Medical Device Regulators Forum , Artificial Intelligence , Systems Using Machine Learning , Risk Management , மென்பொருள் ஆபத்து மேலாண்மை , தகவல் தொழில்நுட்பம் , சர்வதேச மருத்துவ சாதனம் கட்டுப்பாட்டாளர்கள் மன்றம் , செயற்கை உளவுத்துறை , அமைப்புகள் பயன்படுத்தி இயந்திரம் கற்றல் , ஆபத்து மேலாண்மை ,