VP, Chief Product Security Officer, Illumina
Oleg Yusim
SaMD, Digital Ecosystems and the New Rules for Cybersecurity
Cybersecurity expectations for medical devices just shifted again. On June 27, 2025, the FDA issued its updated Cybersecurity in Medical Devices guidance, expanding requirements for “cyber devices,” clarifying FDORA §524B obligations, and reinforcing expectations around SBOMs, vulnerability disclosure, and update planning.
If you’ve already been working to meet the FDA’s 2023 requirements, you may be asking: What’s different this time? Where has the FDA provided more clarity? And how can you demonstrate “reasonable assurance of cybersecurity” in a world where software-driven devices now operate as part of larger digital ecosystems that include mobile apps, cloud services, and connected care platforms?
Join Orthogonal and a panel of experts as we break down what’s new in the 2025 guidance, compare it to the 2023 version, and provide practical insights you can apply directly to your regulatory and engineering strategies.
What We’ll Cover:
- Key updates in the June 2025 guidance and how they impact upcoming submissions
- What FDORA §524B means for “cyber devices,” plus the documentation FDA now expects
- Expanded requirements for SBOMs, vulnerability disclosure, and update planning so you can avoid review delays
- How FDA will evaluate “reasonable assurance of cybersecurity” both for stand-alone devices and for products embedded within digital ecosystems of healthcare and consumer technologies
- Practical steps to incorporate these changes into development, QMS, and compliance workflows
Who Should Attend?
- Regulatory & Quality Leaders – Anticipate evolving compliance requirements before they create bottlenecks.
- Executives & Business Leaders – Understand the business risks of non-compliance and the resources needed to stay ahead.
- Product & Engineering Cybersecurity Teams – Learn how to adapt development practices without slowing innovation.
Don’t get caught off guard. Register today to gain expert insights that will help your team stay compliant, secure, and ready for a connected future.
Founder, Blue Goat Cyber
Christian Espinosa
VP of Regulatory & Quality, Orthogonal
Megan Graham
Chief Solutions Officer, Orthogonal
Randy Horton
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