Description

Architectural views play a pivotal role in demonstrating the cybersecurity posture of a medical device in FDA 510(k) submissions. The FDA expects, at a minimum, four distinct types of architecture diagrams. These diagrams provide a concise, intuitive way to illustrate how security has been built into your device. Well-designed security architectural views allow FDA reviewers to quickly confirm that the threat surface has been fully addressed, that appropriate controls exist across all eight FDA cybersecurity categories, and that identified risks are mitigated. In short, clear and complete diagrams not only reduce reviewer questions but can also significantly streamline the review process and support faster premarket clearance. 

In this webinar, part of our Cybersecurity in Medical Devices: Practical Advice for FDA’s 510(k) Requirements series, we will present a complete set of security architectural views aligned with FDA expectations. 

By walking through these diagrams, we will cover: 

• Four types of security architecture diagrams the FDA recommends 
• Maintaining traceability to your threat model and risk assessment 
• Practical steps for developing effective diagrams 
• Key takeaways from Appendix II of the FDA’s guidance on architecture documentation 
• Why including system overviews, entry points, and security controls makes sense 
• Sample security diagrams based on the AMPS example from the MITRE Playbook for Threat Modeling Medical Devices 

Following the webinar, the example architectural views will be made available. 

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Speakers: 

Milton Yarberry ICS
Milton is the Director of Medical Programs for ICS. He is a certified PMP and Scrum Master with a background in software architecture, medical device product development and program management. He has 20 years in product development with 10 years in software consulting and 15 years working with Class II and Class III medical device manufacturers. 

Colin Duggan BG Networks
Colin is the founder and CEO of BG Networks. Before founding BG Networks in 2020, Colin worked at Analog Devices (ADI) for 29 years in various engineering, management, and marketing leadership roles managing teams located in the U.S., China, Europe, and India. Colin’s experience includes work in automotive, consumer, industrial, and aerospace & defense markets.