MedSec Academy 005: Cybersecurity Architecture Views for Medical Devices

Description: Of the many expectations in the new FDA Premarket Cybersecurity guidance, Cybersecurity Architecture Views have been one of the more challenging deliverables for medical device manufacturers to meet. The need for multiple diagrams and the level of detail needed in each view has caught many manufacturers by surprise. This course will help manufacturers better understand how to approach the Architecture Views and develop strategies for how to make these more successful in their submissions and useful throughout the device lifecycle.

​Event Details:

• Lead Presenter - Matt Hazelett - Chief Operating Officer & Chief Quality Officer
• Date: October 22, 2025 (4 hours)
• Time: 9:00 AM to 1:00 PM (Eastern Time)
• Location: Online

Audience: This course is for staff at medical device manufacturers who are responsible for generating or reviewing Threat Modeling and Architecture Views documentation for medical devices.

Planned Agenda:

1. Describe the structure of Architecture Views and their benefits to medical device manufacturers
2. Discuss the similarities and differences between Threat Modeling and Architecture Views
3. Identifying when different Views are applicable to a medical device
4. Understand how Architecture Views can be used throughout the Total Product Lifecycle