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FDA Cyber Guidance: Implications for SOUP and OTS Risk Management

February 14, 2024

In this webinar, former head of AI/ML for Amgen's Medical Device Division Erez Kaminski, former Cybersecurity SME at MITRE Gabriel Pascualy, and Ketryx Senior Developer Anton Rieder delve into the implications of the new FDA Cybersecurity Guidance on the risk management of SOUP and OTS, with a focus on open-source software. They cover best practices for proactively shifting cybersecurity to the earlier stages of development, often referred to as "shifting left," while also exploring the important considerations and potential gaps to be aware of when selecting cybersecurity tools originally intended for non-medical use cases.

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