EU MDR Cybersecurity Auditor Preparation Course by Tonex
Complex devices, evolving threats, and rigorous regulation collide in this focused program that trains you to evaluate cybersecurity readiness with precision. You will learn how to interpret EU MDR expectations, scrutinize evidence, and conduct auditor-style reviews aligned to Notified Body practices. Impact on cybersecurity is practical and measurable: participants learn to verify controls that reduce exploitability, protect patient safety, and ensure resilient clinical operations. You will translate GSPR 17 into auditable criteria, test documentation depth, and evaluate 81001-5-1 processes so findings are defensible, actionable, and improvement-driven.
Learning Objectives
- Apply EU MDR structure and terminology to cybersecurity evaluations
- Map device risks to auditable controls and objective evidence
- Assess technical file contents for completeness and traceability
- Evaluate process conformance to IEC/TR 81001-5-1 across the lifecycle
- Formulate clear, defensible nonconformities and CAPA expectations
- Explain how cybersecurity risk reduction supports patient safety and regulatory conformity
Audience
- Cybersecurity Professionals
- Regulatory Affairs Specialists
- Quality and Compliance Managers
- Clinical Engineering Leaders
- Product Security and Risk Managers
- Notified Body and Internal Auditors
Course Modules
Module 1 – MDR Audit Foundations
- Scope of MDR and key definitions
- Roles of manufacturer and Notified Body
- Audit lifecycle and evidence expectations
- Risk management link to cybersecurity
- Objective evidence vs. claims and statements
- Grading and writing nonconformities
Module 2 – Technical File Assessment
- Device description to security architecture mapping
- Threat modeling artifacts and assumptions
- SBOM depth, provenance, and maintenance plans
- Patch, update, and vulnerability handling strategy
- Residual risk rationale and acceptance criteria
- Traceability from requirements to verification
Module 3 – GSPR 17 Conformity
- Interpreting GSPR 17 into audit checkpoints
- Authentication, authorization, and encryption controls
- Data integrity, logging, and forensic readiness
- Safety-security co-engineering and usability impacts
- Legacy and SOUP considerations under MDR
- Test evidence and acceptance metrics alignment
Module 4 – IEC/TR 81001-5-1 Processes
- Secure SDLC policy and governance controls
- Security requirements capture and validation
- Design reviews, verification, and independence
- Vulnerability management and coordinated disclosure
- Change control, configuration, and release security
- Supplier, cloud, and third-party assurance
Module 5 – Notified Body Audit Readiness
- Readiness plan, scoping, and sampling strategy
- Evidence packs, indexes, and interview flow
- Demonstrating risk-based prioritization of controls
- Common NB questions and effective responses
- Creating CAPA narratives that withstand scrutiny
- Aligning PMS and PSUR with cybersecurity signals
Module 6 – Reporting and Follow-up
- Classifying findings and linking to clauses
- Writing clear, objective audit reports
- Remediation planning, timelines, and owners
- Verifying effectiveness and closing actions
- Post-market surveillance and incident lessons
- Management reviews and continuous improvement
Elevate your audit capability and accelerate MDR readiness. Enroll now to master evidence-based cybersecurity evaluations that satisfy Notified Bodies and strengthen device safety.