How can security architecture views strengthen a medical device manufacturer’s FDA submissions?

This episode/webinar dives into the four critical security architecture views required by the FDA: global system, multi-patient harm, updatability and patchability, and secure use case views. Christian Espinosa and Trevor Slattery explain how each view strengthens product security while aligning with regulatory expectations. They also share practical strategies and examples, from cloud environments to physical updates, highlighting how proper documentation and foresight can mitigate real-world risks.

Highlights:

(01:19) Learn why the FDA requires four specific security architecture views and how they support threat modeling.

(03:10) Understand how integrating security into architecture views reflects secure coding and DevSecOps practices.

(04:15) Discover how global regulators beyond the FDA use similar documentation requirements.

(07:52) Explore why global system views must include both software and hardware components as well as data flows.

(11:02) The distinction between global system views and multi-patient harm views.

(14:36) Common vulnerabilities like hard-coded credentials that can lead to multi-patient harm.

(19:18) The risks of over-the-air updates versus physical updates for medical devices.

This episode was brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cyber-criminals by visiting https://bluegoatcyber.com

If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session

Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Technology Officer / Director of MedTech Cybersecurity at Blue Goat Cyber.

Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/

Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9

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Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/

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