Stage 1 · 2-7 years out

Build cybersecurity into the architecture before you lock the design

While you're still designing the device

The cheapest place to fix a security issue in a medical device is on a whiteboard. Once silicon, firmware, BLE stacks, and cloud topology are committed, every change becomes a redesign. We help concept- and design-stage teams bake threat modeling, control selection, SBOM strategy, and a Secure Product Development Framework into the device from the first architecture review.

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What we deliver

How we move you through concept & design

Architecture-level threat models aligned with AAMI TIR57 and SW96
Security control selection mapped to your intended FDA pathway
SBOM strategy and toolchain set up before first commit
Secure Product Development Framework (SPDF) ready for Section 524B

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Services that fit this stage

Premarket

Secure MedTech Product Design

Architecture review, control selection, and secure development guidance from concept through V&V - aligned with FDA's Secure Product Development Framework.

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Medical Device Threat Modeling

Comprehensive threat modeling per FDA Section V.A.1 - covering supply chain, deployment, environment of use, and decommission risks for the full device system.

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FDA-Compliant SBOM Services

Machine- and human-readable SBOMs with NTIA minimum elements (superseded by CISA's 2026 Minimum Elements for an SBOM, published July 29, 2026), vulnerability mapping, and end-of-support tracking - built for FDA review.

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Next stage →

Premarket Submission

Submission is on the calendar - you have time to get it right

Stage 1 · 2-7 years out

Ready to take on concept & design?

Free 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.

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