All topics
Structured walk-throughs organized by lifecycle phase - from concept through incident response.
Concept
5 topicsOverview
Start here. The big picture for MedTech security.
Why It Matters
The case for taking cybersecurity seriously: patients, brand, and revenue.
SPDF
Bake security into every stage of the device lifecycle.
Threat Modeling
Identify and reason about threats before they ship.
AI/ML Devices
Adversarial ML, model integrity, PCCPs, and the security surface unique to learning-enabled devices.
Premarket
6 topicsOverview
Start here. The big picture for MedTech security.
SPDF
Bake security into every stage of the device lifecycle.
Threat Modeling
Identify and reason about threats before they ship.
Pentesting
What's in scope (hardware, firmware, wireless, cloud, mobile), the methods reviewers expect, and how to read a pentest report against FDA cybersecurity guidance.
Premarket
Submit a cybersecurity package the FDA will accept.
AI/ML Devices
Adversarial ML, model integrity, PCCPs, and the security surface unique to learning-enabled devices.
Submission
3 topicsOverview
Start here. The big picture for MedTech security.
Premarket
Submit a cybersecurity package the FDA will accept.
FDA Response
Turn an FDA cybersecurity hold into a clean clearance.
Postmarket
6 topicsOverview
Start here. The big picture for MedTech security.
Pentesting
What's in scope (hardware, firmware, wireless, cloud, mobile), the methods reviewers expect, and how to read a pentest report against FDA cybersecurity guidance.
Postmarket
Stay compliant and secure after your device is on the market.
Monitoring
Continuous vulnerability monitoring for fielded devices.
AI/ML Devices
Adversarial ML, model integrity, PCCPs, and the security surface unique to learning-enabled devices.
Vuln Management
The end-to-end lifecycle: discovery, CVSS/rubric assessment, coordinated disclosure (CVD), and patch validation for fielded medical devices.