All phases
Journey phase
Concept
Defining the device, risks, and security architecture.
5 guides · 47 curated tips
Your journey progress
1 of 5 phases explored · saved on this device
What to focus on
Topics for the concept phase
6 tips
Overview
Start here. The big picture for MedTech security.
10 tips
Why It Matters
The case for taking cybersecurity seriously: patients, brand, and revenue.
7 tips
SPDF
Bake security into every stage of the device lifecycle.
12 tips
Threat Modeling
Identify and reason about threats before they ship.
12 tips
AI/ML Devices
Adversarial ML, model integrity, PCCPs, and the security surface unique to learning-enabled devices.
Related resources
Checklists for concept and premarket
Premarket · 6 min read
FDA Premarket Cybersecurity Submission Checklist
Section-by-section checklist mirroring FDA's RTA cybersecurity items: security risk management, SBOM, threat model, testing evidence, labeling, and CVD policy.
SBOM · 5 min read
SBOM Quality & VEX Readiness Checklist
What every cybersecurity reviewer (FDA or hospital) looks for in an SBOM: format, depth, signatures, hashes, supplier identification, and paired VEX statements.