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Medical Device Threat Modeling Practitioner (FDA + MDR) Essentials

Length: 2 Days
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Medical Device Threat Modeling Practitioner (FDA + MDR) Essentials Training by Tonex

Medical Device Threat Modeling Practitioner (FDA + MDR) Essentials

Elevate your capability to design, assess, and defend connected medical technologies with a practitioner-focused program that blends security engineering, safety risk thinking, and regulatory alignment. You will learn to build accurate DFDs, apply STRIDE, DREAD, and LINDDUN in clinical contexts, and map mitigations to FDA and EU MDR expectations.

Cybersecurity impact is front and center—participants translate threat models into verifiable controls that reduce patient risk and protect PHI. You will leave with repeatable methods to anticipate adversaries, harden device-software-ecosystem boundaries, and communicate evidence suitable for premarket submissions and postmarket surveillance.

Learning Objectives

  • Build trustworthy DFDs for connected devices and clinical workflows
  • Apply STRIDE, DREAD, and LINDDUN to device, app, cloud, and hospital interfaces
  • Derive safety-security co-analysis and tie to ISO 14971 and IEC 62304
  • Produce attacker-centric artifacts such as attack trees and misuse cases
  • Document controls and residual risk aligned to FDA and EU MDR expectations
  • Demonstrate measurable cybersecurity impact in threat modeling deliverables

Audience

  • Product Managers and Systems Engineers
  • Medical Device Software Engineers
  • Risk and Quality Engineers
  • Regulatory Affairs Specialists
  • Clinical IT and HTM Professionals
  • Cybersecurity Professionals

Course Modules

Module 1 – Foundations

  • Devices in care ecosystems
  • Regulations landscape overview
  • Threat modeling value chain
  • Security vs safety alignment
  • Data, trust, and assets
  • Evidence and documentation

Module 2 – DFD Mastery

  • Scoping system boundaries
  • Trust zones and assumptions
  • Data stores and flows
  • External entities and actors
  • Protocols and interfaces
  • DFD review checklist

Module 3 – STRIDE and DREAD

  • STRIDE for device nodes
  • STRIDE for data flows
  • DREAD scoring calibration
  • Severity and patient impact
  • Mitigation patterns library
  • Traceability to controls

Module 4 – LINDDUN for Privacy

  • Linkability and identifiability
  • Non-repudiation pitfalls
  • Detectability in hospitals
  • Privacy threat elicitation
  • PHI flows and minimization
  • Privacy control selection

Module 5 – Attack Trees

  • Goal and subgoal framing
  • Workflow-centric attacks
  • Multi-step kill chains
  • Safety-security couplings
  • Countermeasure insertion
  • Tree to test mapping

Module 6 – Safety-Security Co-Analysis

  • ISO 14971 integration points
  • Hazard to threat linking
  • IEC 62304 work products
  • Premarket submission alignment
  • Postmarket monitoring loop
  • Residual risk acceptance

Ready to turn threat modeling into regulatory-grade evidence and safer patient outcomes? Enroll in the Medical Device Threat Modeling Practitioner (FDA + MDR) Essentials Training by Tonex and build a repeatable, auditable practice that your engineering, quality, and regulatory teams can trust.

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