AI/ML in Medical Devices: U.S. and EU Regulatory Perspectives – Webinar Recording/Transcript
Product Details
New U.S. and European guidance and governances for AI/ML-enabled medical devices are looming, and the efforts to standardize regulations will inevitably form a mushroom cloud of disparate expectations around the globe.
It begs the question: Do you have an AI quality management system in place that will satisfy the regulators?
In this presentation, Eric Henry, senior quality systems and compliance advisor of the FDA & Life Sciences Practice at the King & Spalding law firm, will explain why devicemakers need a full understanding of these upcoming reforms as well as what the future will bring.
Presentation Takeaways:
- The importance of making the most of current and pending US/EU regulatory frameworks for AI/ML medical devices.
- The role of the FTC in regulating AI, and how it will impact the medical device industry.
- The far-reaching implications of upcoming draft guidances, including predetermined change control plans [PCCPs], lifecycle management considerations, and recommendations for premarket submissions.
- Upcoming final guidances, such as the EU’s landmark AI Act.
As regulators develop new regulations, guidances and standards specific to AI/ML-enabled devices, there’s no better time than now to tailor your quality management systems to accommodate them.
Meet Your Presenter
Eric Henry, senior quality systems and compliance advisor of FDA & Life Sciences Practice at King & Spalding law firm, is a veteran of the industry of more than 33 years. Since 2018, he has provided advisory and consulting services focused on regulatory compliance, enforcement and policy matters for industries regulated by the FDA. Henry delivers topnotch guidance on FDA requirements to professionals in medical device manufacturing, including but not limited to quality systems requirements, inspection preparedness and post-market obligations. He also advises corporate management and boards on their responsibilities and expectations of the FDA.
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Who Will Benefit
- All levels of leadership at medical device companies
- Quality assurance staff
- Regulatory affairs staff
- General counsel
- Consultants supporting medical device companies