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on-demand webinar

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

January 17, 2024
4:00 pm
Recorded on 
January 17, 2024

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.

What you'll learn

  • The role of SOUP/OTS in medical application development with a focus on the importance and risks of open-source software.
  • Implications of the new FDA OTS Guidance on your existing SOUP/OTS management processes.
  • Best practices and tools for OTS risk assessment and mitigation at scale.

Who should attend

  • Research and development leaders and managers
  • Regulatory affairs and compliance personnel

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Erez Kaminski

Founder & CEO

Gabriel Pascualy

Cybersecurity SME, former Principal Investigator at MITRE


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