Patient safety comes first. These guides explain what each regulator and standard asks for and how the pieces fit. Start with your market and your stage.
Answer two questions. You get a short reading order.
1. Where will the device be sold?
2. Where is the device today?
Start here for the US market.
The statutory duties for cyber devices.
What each deliverable is and where it goes in eSTAR.
A final check before you submit.
Monitoring, disclosure, and patching after launch.
Start here for the EU market.
Evidence mapped to the requirements.
Build one evidence set for both markets.
For devices with AI or machine learning.
Which standard covers what.
Secure lifecycle evidence, activity by activity.
How security risk connects to patient safety risk.
Component and system security evidence.
Validating the tools you rely on.
30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
