Events & Speaking Engagements
About MedSec
FREE: FDA Cybersecurity Architecture Views: The What? Why? When? and How to Get Started?
with Matt Hazelett, Chief Regulatory Officer
Feb 27, 2025 1:00 PM in EST
With Matt Hazelett, Chief Regulatory Officer
Description: One of the most challenging and new documentation deliverables in the 2023 FDA Guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” are the Architecture Views. These Architecture Views are frequent deficiencies from the FDA in premarket submissions and can be challenging to create late in the development process or during a deficiency hold.
In this webinar, we will break down what the Architecture Views are, why FDA is asking for them, when to start developing them, and how to get started making them. Attendees will have the opportunity to engage in a Q&A session to address questions about the Architecture Views and approaches to drive success.