The best teams don't threat model for the FDA. They do it to find design weaknesses before attackers do. MSI drafts from the architecture you already have, in the methodology you already use. The security insight is the win. The compliance artifact is the icing.
STRIDE, attack trees, and other recognized frameworks. We work in the model your team already uses, not one we impose.
Works from the AWS, Visio, and Draw.io diagrams and source repos you already maintain. No new format, no blank page.
The threat model feeds your security risk assessment and ISO 14971 process. One connected workflow.
Working through your architecture surfaces the design weaknesses you'd otherwise meet in a pen test, or in the field. Customers tell us the exercise improved their architecture before any document was filed.
A blank page gets one SME through one device a quarter. With MSI drafting scenarios to react to, the same team covers the portfolio. No new headcount, no stale models.
Built to recognized methodologies and checked by former FDA reviewers, the submission artifact falls out of the work. Your experts do security. The compliance check happens at the end.
We ingest the diagrams, system descriptions, and source repos your team already maintains. No starting over.
MSI drafts scenarios and attack trees in your methodology, then flags inconsistent scoring and structural gaps. Accuracy, not volume.
Your SMEs decide what's complete. Our former FDA reviewers verify it holds up. The model stays current across the lifecycle.
Scenarios and attack trees drafted from your architecture, in your methodology. A fast first pass for your experts to refine, not a black box.
Flags inconsistent CVSS scoring, structural gaps, and mismatches with reviewer expectations. Right, not just long. CVSS 3.1 now, 4.0 coming.
Ask questions of FDA cybersecurity guidance, vulnerability data, and threat intelligence in plain language while your team works.
Structured output that drops into your ISO 14971 and AAMI SW96 templates.
Most tools generate a model and call it done. Medcrypt keeps your experts in charge, and pairs them with former FDA CDRH premarket reviewers and contributors to MDIC's Playbook for Threat Modeling Medical Devices and the MITRE Rubric for Applying CVSS to Medical Devices. Automation for speed, reviewers for judgment.
Former FDA CDRH reviewers · STRIDE, attack trees, and other recognized methodologies · AAMI SW96 · IEC 81001-5-1 · ISO 14971 · Section 524B aligned · Lifecycle maintained
One working session. Your device, your architecture, your methodology.
Book a threat-model review