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Regulation, Clinical and Software for Medical Devices

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November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota

Eric Henry
Senior Quality Systems and Compliance Advisor at King & Spalding LLP
Speaker

Profile

Eric Henry is a Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding. In this role Eric advises King & Spalding clients on a variety of regulatory compliance matters, including the establishment, remediation, and defense of quality systems; establishment of quality organizations; compliance-related due diligence reviews for M&A; training; and serving as an expert witness during litigation.

He also participates in various medical device industry working groups and committees collaborating with manufacturers, healthcare providers, regulators, and academia in areas of focus such as artificial intelligence, cybersecurity, and software design controls.

Eric joined King & Spalding in 2018 after 30 years in the medical device industry leading global organizations through a wide variety of quality and compliance challenges.

Agenda Sessions

  • Quaking about Quality? Digesting the Harmonization of Quality Management System Regulation (QMSR) with ISO 13485

    9:40am