Software (and AI) as a Medical Device – Regulatory Pathways and Guidance to the Industry (Panel)

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Moderator:
Priya Mannan, Global Head of Compliance and Data Privacy, Novartis

Panelists:
Bahram Parvinian, Former Senior Technical Reviewer of Smart Algorithms & Monitoring Devices, FDA and Current Founder & Principal Consultant, Lighthouse Regulatory and Technical Consulting
Ram Mannan, Founder, Magnacarta
Mark Ostrowski, Head of Engineering, US East, Check Point
Jacob Agris, Medical Advisor to Head of R&D, Bayer

Panel Abstract:
Digital technologies in the form of software have incredible potential to unlock the next chapter of medical innovation and to help patients take control of their own health. When clinically validated the software-based therapeutics provide for better outcomes to patients with enhanced compliance and tracking for physicians with a cost-effective solutions for payers.Explore the recent FDA guidance for Software as a Medical Device. What should companies look for in the next few years to get their product to market faster and still be complaint under the new guidance.