Insights & News

Galen Data Webinar: Reducing AI Risk to Secure Regulatory Approval

April 4, 2023
SaMD & Digital Health
Compliance & Regulatory: MedTech
Learn from Isabella Schmitt, our Director of Regulatory Affairs, who is partnering with Galen Data to discuss, "Reducing AI Risk to Secure Regulatory Approval."

Are you considering the right factors to reduce AI risk to secure regulatory approval for your device?

In this webinar powered by Galen Data, Isabella Schmitt, MBA, RAC, Proxima's Directory of Regulatory Affairs will cover why artificial Intelligence (AI) is a powerful technology that is changing the MedTech industry as we know it today. Are you approaching AI implementation into your device with intention and from an FDA regulatory perspective?  If you're considering building a medical device that incorporates AI, it's important to be aware of the potential risks associated with this technology. We will explore the impact of AI for medical device development, the potential risks associated with incorporating this technology into your devices, and how to design your algorithm with a clear vision of the end-user in mind.

Watch the 1 hour webinar with questions and answers from the audience at the end, here.

Specifically, this webinar will cover

  • Make sure your algorithms are generalizable to your patient population
  • Be mindful of how biases can be introduced
  • How to make your algorithm more transparent for the end user and for the FDA

More About The Speaker

Isabella Schmitt, MBA, RAC is the Director of Regulatory Affairs at Proxima Clinical Research, a contract research organization guiding emerging MedTech and Biotech companies through regulatory, quality, and clinical development. She leads 200+ medical device and pharma projects and oversees the marketing team. Outside of Proxima, Isabella is a partner, judge, mentor, and speaker for multiple healthcare accelerators, including M1 MedTech Accelerator, MedTech Innovator, TMCi, MassChallenge, gBEta, and Hatch.  She also serves as a pitch coach for SXSW Pitch Competition.