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

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.