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Quality & Regulation Track

Can ChatGPT Assist with Risk Management? A Guide to Conducting Risk Management for Medical Devices Incorporating ML/AI

Can ChatGPT Assist with Risk Management? A Guide to Conducting Risk Management for Medical Devices Incorporating ML/AI

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Israel A. Citron MBA, MSc.

VP Regulatory Affairs and Quality Assurance, Pulsenmore

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Applying Human Factors to Make Safe and Effective Medical Devices and Meet US and EU Regulatory Requirements

Applying Human Factors to Make Safe and Effective Medical Devices and Meet US and EU Regulatory Requirements

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Becky Moses

Human Factors Practice Leader, Core Human Factors

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Advertising Medical Devices in the Age of Innovation: Navigating Regulatory Challenges and Opportunities

Advertising Medical Devices in the Age of Innovation: Navigating Regulatory Challenges and Opportunities

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Adv. Limor Tarsi-Chen

Founder & Owner, LTC Law Office

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FIH Fast Track

FIH Fast Track

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Liat Diamant Porat

CEO, LDP Consulting

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Beyond the Checklist - Why Regulatory Submission of Medical Device Software Requires More Than You Expected

Beyond the Checklist - Why Regulatory Submission of Medical Device Software Requires More Than You Expected

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Dina Sifri

Founder and CEO, MedDev Soft

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Cybersecurity in Medical Products and Services – What Penetration Testing Means?

Cybersecurity in Medical Products and Services – What Penetration Testing Means?

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Erez Metula

CEO, AppSec Labs

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AI Tools in SW Validation

AI Tools in SW Validation

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Yael Nuss

SW Validation Expert, R.S NESS Group

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Navigating EU MDR Technical File Submissions – Lessons Learned

Navigating EU MDR Technical File Submissions – Lessons Learned

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Dana Manaim Tirosh

QA RA Senior Project Manager - EU MDR SME, Gsap

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