New FDA OTS Guidance: How to Manage Risk and Testing at Scale

In this session, we will 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. Additionally, we'll explore the critical aspect of cybersecurity in medical devices, discussing quality system considerations and the content of premarket submissions. You'll gain valuable insights into best practices and tools for OTS risk assessment and mitigation at scale, as well as identifying gaps in traditional dependency management tools.