Threat Modeling (FDA-mandated) Fundamentals Training by Tonex
Modern connected devices demand disciplined analysis of how systems fail under adversarial pressure. This course equips teams to build FDA-compliant threat models that trace risk from architecture to exploitable pathways and documented mitigations. You will learn a practical toolkit—STRIDE, attack trees, and DFDs—tailored to medical technologies and digital health ecosystems. Impact on cybersecurity is immediate: participants identify high-risk interfaces early, prioritize controls with evidence, and defend design decisions during reviews. Stronger cybersecurity posture reduces recall risk, accelerates submissions, and improves patient trust by demonstrating rigorous, testable security requirements.
Learning Objectives
- Apply FDA-mandated threat modeling to medical device and digital health contexts
- Construct DFDs that expose trust boundaries and abuse-prone data flows
- Use STRIDE and attack trees to enumerate credible, testable threats
- Prioritize mitigations using likelihood, impact, and exploitability criteria
- Produce auditable outputs for premarket and postmarket dossiers
- Communicate how threat modeling strengthens cybersecurity outcomes
Audience
- Cybersecurity Professionals
- Product Managers and Owners
- System and Software Engineers
- Quality and Regulatory Affairs Specialists
- Risk Management and Safety Engineers
- Cloud and Mobile Architects
Course Modules
Module 1 – FDA Basics
- Scope and definitions
- Premarket expectations
- Postmarket vigilance
- Risk management linkage
- Documentation artifacts
- Reviewer perspectives
Module 2 – Governance & Standards
- Alignment with AAMI TIR57
- Mapping to IEC 81001-5-1
- Connections to ISO 14971
- Evidence for submissions
- Traceability to controls
- Change management triggers
Module 3 – STRIDE & Trees
- STRIDE categories clarified
- Attacker goals to leaves
- Building attack trees
- Ranking paths by effort
- Countermeasure mapping
- Residual risk rationale
Module 4 – DFDs That Work
- Trust boundary identification
- Process and store semantics
- External entity modeling
- Data flow correctness
- Elevation of privilege checks
- DFD review checklist
Module 5 – High-Risk Pathways
- Cloud attack surfaces
- BLE pairing weaknesses
- Wi-Fi enterprise pitfalls
- API auth and rate limits
- OTA and update channels
- Telemetry and PHI flows
Module 6 – Execution Playbook
- Workshop cadence and roles
- Threat library tailoring
- Severity and scoring model
- Mitigation patterns catalog
- Evidence packaging tips
- Continuous improvement loop
Ready to close one of the biggest gaps in industry and demonstrate robust, auditable security by design? Enroll your team in Threat Modeling (FDA-mandated) Fundamentals Training by Tonex to turn regulatory expectations into a decisive engineering advantage.