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Breakout

Breakout #1: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update

Thursday, April 24, 2025
9:55 AM – 11:25 AM East Coast USA Time
Location: Delaware AB – 2nd Floor
This session will explore FDA’s review and enforcement activities considering its increased statutory authority and its latest premarket cybersecurity guidance. The session will also provide an update on the current and future global regulatory landscape around medical device cybersecurity.

    Moderator(s)

  • Eric Henry

    Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice
    King & Spalding LLP

    • Speaker(s)

  • Axel Wirth

    Chief Security Strategist
    MedCrypt

  • Chris Reed

    Senior Director of Cybersecurity Policy, Global Regulatory Affairs
    Medtronic