Cyber Risk Management (ISO 14971) Under MDR Fundamentals Training by Tonex
Medical devices now operate within complex, connected ecosystems where safety and security intersect. This course equips teams to apply ISO 14971 risk management within the EU MDR context, extending traditional hazard analysis to include cyber-originating scenarios and their downstream clinical effects. You will learn practical ways to identify cyber hazards, map harm chains from data compromise to patient impact, and document risk controls that satisfy auditors. On cybersecurity, we explore threat-informed risk estimation, security-by-design controls, and evidence expected by Notified Bodies. You leave with templates, traceability tactics, and review-ready documentation practices.
Learning Objectives
- Apply ISO 14971 process steps end to end
- Align risk management files with MDR expectations
- Identify cyber hazards across device, network, and cloud paths
- Trace cyber harm to clinical harm with evidence
- Use AAMI TIR57 methods for cyber risk analysis
- Prioritize controls using risk acceptability criteria
- Communicate cybersecurity impact on patient safety and compliance
Audience
- Product Managers
- Systems and Software Engineers
- Regulatory Affairs Specialists
- Quality and Risk Management Leads
- Clinical Safety Officers
- Cybersecurity Professionals
Course Modules
Module 1 – ISO 14971 Basics
- Risk management plan essentials
- Intended use and misuse
- Hazard, sequence, situation, harm
- Risk estimation techniques
- Risk control option analysis
- Residual risk evaluation
Module 2 – MDR Alignment
- GSPRs and Annex I mapping
- RMF and technical documentation
- Post-market surveillance linkage
- Clinical evaluation interfaces
- Notified Body expectations
- Benefit–risk determination
Module 3 – Hazard Identification
- Cyber risk hazard catalogs
- Device, app, cloud assets
- Interface and data flows
- Threat sources and events
- Abuse and foreseeable misuse
- Supply chain and SBOM cues
Module 4 – Cyber-to-Clinical Harm
- Harm chain modeling steps
- Loss of confidentiality path
- Loss of integrity scenarios
- Loss of availability impacts
- Clinical workflow disruptions
- Severity and detectability
Module 5 – AAMI TIR57 Methods
- Asset–threat–impact triads
- Security risk scoring inputs
- Trust boundaries and zones
- Control families and goals
- Residual cyber risk rationale
- Documentation exemplars
Module 6 – Documentation and Evidence
- Traceability matrix structure
- Verification and validation ties
- SOUP and legacy components
- Change control and reanalysis
- PMS and vigilance feedback
- Audit-ready file organization
Advance your team’s ability to demonstrate safety and security under MDR. Enroll today to master cyber hazard identification, prove the link between cyber and clinical harm, and apply AAMI TIR57 within an ISO 14971 framework that stands up to regulatory scrutiny.