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 FDAnews webinar, 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.

In this webinar, you’ll learn about:

  • 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.

Who Will Benefit:

  • All levels of leadership at medical device companies
  • Quality assurance staff
  • Regulatory affairs staff
  • General counsel
  • Consultants supporting medical device companies