AI & Machine Learning in Medical Device

In our first episode of RCA Radio, host Erika Porcelli and guest Lisa Michels, General Counsel & Regulatory Affairs Expert at Regulatory Compliance Associates (RCA), examine the FDA’s proposed regulatory framework for modifications to artificial intelligence and machine learning (AI/ML)-based software as a medical device.

We dive into the FDA discussion paper, what AI/ML software are and how they work in medical devices, and discuss how potential risk factors resulting from this software’s ability to adapt or change have led the FDA to propose a new total product lifecycle approach, eliciting industry feedback in the process.

For full Transcript click here.

To watch the video podcast click here.

Interested in Learning More?

Contact Us
We use cookies in order to give you the best possible experience on our website. By continuing to use this site, you agree to our use of cookies.