Eric HenrySenior Quality Systems and Compliance Advisor at King & SpaldingSpeaker
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
Regulating AI/ML: Where Are We Now?
, 09:25View SessionChairperson’s Opening Remarks: Software and AI for Medical Devices & IVDs
, 08:45View SessionShared Experiences: Developing Effective Quality Management Systems (QMS) for AI
, 11:40View SessionChairperson’s Afternoon Remarks: Software and AI for Medical Devices & IVDs
, 13:25View Session