[Skip to main content](https://www.ketryx.com/learn/webinars/on-demand/new-fda-soup-ots-guidance-managing-risk-and-testing-at-scale#)

Free Webinars

# New FDA SOUP/OTS Guidance: Managing Risk and Testing at Scale

January 17, 2024

45

minutes

Webinar Full Recording New FDA SOUPOTS Guidance- Managing Risk and Testing at Scale

Click for sound

This browser does not support HTML video.

Click for sound

Founder and CEO Erez Kaminski and former Principal Investigator, Device Security & Cyber Physical Systems for MITRE Gabriel Pascualy delve into the latest 2023 FDA guidances, with a particular focus on the use of SOUP and Off-The-Shelf Software (OTS) in medical devices and the content of premarket submissions for device software functions.

After answering audience questions, a brief demo on how Ketryx addresses the OTS management and risk management regarding the use of SOUP items.

Are You Building Medical Software?

## Get started building software in minutes, not months.

[Book a demo](https://www.ketryx.com/schedule-demo)

.png)