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.
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
Services that fit this stage
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.
Explore service PremarketMedical 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.
Explore service PremarketFDA-Compliant SBOM Services
Machine- and human-readable SBOMs with NTIA minimum elements, vulnerability mapping, and end-of-support tracking - built for FDA review.
Explore serviceReady to take on concept & design?
Free 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.