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Quality & Regulation Track

FDA Pressure Points of AI Regulation

FDA Pressure Points of AI Regulation

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Michael (Moshe) Kasser

Senior Director of Regulatory Strategy, Hogan Lovells

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The Future of Medical Device Regulation: Navigating the MDR/IVDR 2.0 Revision

The Future of Medical Device Regulation: Navigating the MDR/IVDR 2.0 Revision

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Sharon Konforty Wissmark

Project Manager, Lead auditor and Technical documentation Reviewer, DEKRA Certification

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How to Navigate the Usability Journey? Hard-Won Lessons for Israeli Med-Tech

How to Navigate the Usability Journey? Hard-Won Lessons for Israeli Med-Tech

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Yael Shavit, PhD

Senior Usability & UX Expert, Cognit UX Experts

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​Is Europe Still Worth It? MDR, IVDR, and MDSAP as Strategic Market Access Levers

​Is Europe Still Worth It? MDR, IVDR, and MDSAP as Strategic Market Access Levers

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Fatimazahra Meskini and Ehab Amen

Certification Manager, GMED and Certification Director, GMED



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De-Risking Your Use-Related Risk Analysis: Human Factors guidelines for Regulatory Compliance

De-Risking Your Use-Related Risk Analysis: Human Factors guidelines for Regulatory Compliance

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Becky Moses

Human Factors Practice Leader, Core Human Factors



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Change Control - Friend or Foe?

Change Control - Friend or Foe?

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Dr. Dorit Nahari

VP Global Quality and Regulatory Affairs, Insightec‎



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