# Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices

January 15, 2025

,

11:00 am

EST

60

mins

Recorded on

January 15, 2025

60

mins

Generative AI devices hold transformative potential for healthcare, but ensuring their safety and effectiveness demands robust lifecycle management strategies. Building on the FDA’s _Total Product Lifecycle Considerations for Generative AI-Enabled Devices,_ this session provides actionable insights to help you align with regulatory expectations while driving innovation.

## What you'll learn

- Evidence needs for Generative AI devices, including transparency in training datasets, performance metrics, and validation of off-the-shelf Generative AI used in products
- Postmarket monitoring strategies, such as managing evolving foundation models
- Best practices for dataset management, with a focus on traceability and maintaining quality across the product lifecycle

‍

## Who should attend

Register to

watch

attend

Get informed of webinars like this one.

This browser does not support HTML video.

Click for sound

### Clips from this Webinar

## Speakers

### Erez Kaminski

Founder & CEO

[Ketryx](https://www.ketryx.com/)

Formerly

Head of AI, Amgen

### Jenn Dixon

Director of AI Quality & Regulatory Strategy

[Ketryx](https://www.ketryx.com/learn/webinars/register/navigating-the-fdas-total-product-lifecycle-framework-for-generative-ai-devices#)

Formerly

## Interested?

[Register now](https://www.ketryx.com/learn/webinars/register/navigating-the-fdas-total-product-lifecycle-framework-for-generative-ai-devices#register)