By Brad Bernia
Project Manager/Software Engineer
Hey there! If you’re working on a medical device and staring down the barrel of an FDA premarket submission, you’ve probably heard of something called Security Architectural Views. Sounds fancy, right? Don’t worry—I’m here to break it down in plain English.
I’ve spent the past few years navigating the medtech world, and let me tell you, explaining cybersecurity to regulators doesn’t have to be painful. In fact, when you really get into it, Security Architectural Views are a powerful way to tell the story of how your device keeps patients and data safe.
What are Security Architectural Views, Really?
Think of them as a high-level blueprint of how your device handles cybersecurity. These diagrams (or descriptions) show the important security components, how data flows through the system, and where trust boundaries exist. It’s your chance to say, “Here’s how we built security into this device, not bolted it on later.”
These views highlight everything from authentication mechanisms to how updates are handled, helping reviewers see that your design supports strong cybersecurity principles from the start.
Why the FDA Cares
The FDA isn’t just checking boxes—they’re looking for evidence that you’ve thought seriously about risk. Security Architectural Views are a key part of that story. They show that you’ve embedded security into the architecture, aligned with Quality System Regulations, and have a plan to handle threats throughout the device’s lifecycle.
What to Include (And What Not to Forget)
At a minimum, your view should include:
- Sensitive components like authentication, encryption, and remote updates
- Data flows and external interfaces (like mobile apps or cloud)
- Clearly marked trust boundaries
Some features that are often shown: secure boot, TEEs, BLE/Wi-Fi connections, logging infrastructure, and cloud integrations. And don’t forget third-party libraries or external services—they’re part of your attack surface too.
Keep It Simple, Visual, and Relevant
The best architectural views are clear, visual, and easy to follow. Avoid overwhelming technical detail. Label your components, highlight how each contributes to cybersecurity, and tie everything back to your threat model and risk assessment. Think of it as storytelling with diagrams—your goal is clarity, not complexity.
Quick Best Practices
- Label components and trust boundaries clearly
- Show where security controls are applied
- Include all relevant external systems
- Make sure it aligns with your threat model
- Keep diagrams clean and uncluttered
The CriTech Takeaway
At the end of the day, Security Architectural Views are about demonstrating security by design. They help regulators (and your own team) understand how your device defends against threats and keeps patients and data safe. Done right, they’re more than a regulatory requirement—they’re proof that your product is built to last in a connected, high-risk world.
If you’re tackling this part of your submission, take a step back and ask: does this view tell the story of our device’s security? If the answer’s yes, you’re in good shape.