Cybersecurity Risk Management (FDA + ISO 14971/AAMI TIR57) Essentials Training by Tonex
Modern connected medical technologies demand disciplined, defensible risk practices that satisfy regulators and protect patients. This course brings together FDA expectations with ISO 14971 and AAMI TIR57 to help teams design, document, and justify cybersecurity decisions across the product lifecycle. You will learn how to build integrated risk files, map clinical hazards to security threats, and argue assurance levels with evidence. Impact on cybersecurity is front and center, translating threat models into patient safety outcomes and regulatory-ready documentation. You will leave with actionable frameworks for safety–security tradeoffs that withstand audits and accelerate submissions.
Learning Objectives
- Explain how FDA cybersecurity guidance aligns with ISO 14971 and AAMI TIR57
- Build and maintain an integrated safety–security risk file across the lifecycle
- Perform threat identification, misuse cases, and exploitation feasibility analysis
- Determine and justify target assurance levels and residual risk acceptability
- Trace controls to hazards, harms, and risk reductions with objective evidence
- Communicate cybersecurity impact within clinical risk narratives and submissions
Audience
- Cybersecurity Professionals
- Regulatory Affairs Specialists
- Quality and Risk Managers
- Systems and Software Engineers
- Clinical Safety and Usability Leads
- Product and Compliance Leaders
Course Modules
Module 1 – Regulatory Foundations
- FDA expectations for cybersecurity risk management
- ISO 14971 risk process essentials
- AAMI TIR57 threat analysis alignment
- Guidance mapping and terminology harmonization
- Safety versus security risk concepts
- Documentation artifacts auditors expect
Module 2 – Risk File Architecture
- Structure of integrated risk files
- Linking hazards, threats, and harms
- Asset inventories and security characteristics
- Defining risk acceptability criteria
- Version control and traceability norms
- Evidence organization for submissions
Module 3 – Threats and Misuse
- Eliciting misuse, abuse, and threat scenarios
- Attack surface and entry point analysis
- Exploitability and feasibility scoring methods
- Dual risk: patient safety plus cybersecurity
- Environmental and clinical use conditions
- Third-party and supply chain considerations
Module 4 – Controls and Assurance
- Selecting preventive and detective controls
- Safety–security tradeoff decision patterns
- Defense depth and compensating controls
- Assurance level justification techniques
- Cryptography, identity, and hardening basics
- Residual risk evaluation and rationale
Module 5 – Verification and Evidence
- Security requirement verification planning
- Penetration and fuzz testing scoping
- SBOM, vulnerability handling, and patches
- Usability and workflow risk confirmations
- Objective evidence and acceptance criteria
- Review records and independence expectations
Module 6 – Submission and Postmarket
- 510(k)/PMA cybersecurity content planning
- Pre-subs, Q-subs, and reviewer expectations
- Postmarket surveillance and patch strategy
- Coordinated vulnerability disclosure processes
- Field risk assessments and benefit–risk updates
- Continuous improvement and metrics tracking
Ready to align patient safety and cybersecurity while satisfying FDA, ISO 14971, and AAMI TIR57 expectations? Enroll now with Tonex to build risk files, justify assurance levels, and accelerate compliant, secure device releases.