Certified Medical Device Risk Manager (CMDRM)

Certified Medical Device Risk Manager (CMDRM) Certification Program by Tonex

Certified Medical Device Risk Manager prepares professionals to plan, execute, and maintain risk management activities aligned with ISO 14971:2019 across the device lifecycle. Participants learn how to identify hazards, estimate and evaluate risks, implement effective controls, verify risk reduction, and maintain traceability to benefit-risk decisions and regulatory expectations.

The program connects design controls, usability engineering, clinical evaluation, and postmarket feedback into a single, auditable framework. Cybersecurity is addressed as a core safety and performance concern, linking threat modeling and software risk management with safety risk evaluation. Participants gain practical methods to integrate cybersecurity into risk files, coordinate with SBOMs and vulnerability disclosure, and monitor emerging digital threats that could impact clinical performance and patient safety.

Learning Objectives

• Apply ISO 14971 processes across the device lifecycle
• Perform structured hazard identification and risk analysis
• Evaluate benefit-risk and document decision rationales
• Design, verify, and validate risk controls
• Integrate usability engineering with safety cases
• Build postmarket surveillance and CAPA linkages
• Strengthen cybersecurity risk management and threat response

Audience

• Quality and Regulatory Affairs Professionals
• Risk and Compliance Managers
• R&D and Systems Engineers
• Clinical and Safety Specialists
• Product Owners and Project Managers
• Cybersecurity Professionals
• Manufacturers, Suppliers, and Consultants

Course Modules

Module 1: Risk Management Foundations and Governance

• Process scope and interfaces
• Roles and responsibilities
• Risk policy and criteria
• Documentation and records
• Traceability and tools
• Audit readiness practices

Module 2: ISO 14971 Risk Analysis Techniques

• Intended use and misuse
• Hazard identification methods
• FMEA and FMECA basics
• Fault tree analysis
• Hazardous situation mapping
• Probability and severity estimates

Module 3: Risk Evaluation and Decision Making

• Risk acceptability criteria
• Benefit-risk determination
• Uncertainty and assumptions
• Evidence and justification
• Review and signoff flow
• Change impact analysis

Module 4: Risk Control and Residual Risk

• Control option analysis
• Inherent safety by design
• Protective measures selection
• Information for safety
• Verification and validation
• Residual risk evaluation

Module 5: Usability, Software, and Cybersecurity Risks

• Use-related risk linkage
• IEC 62366 alignment
• Software risk concepts
• Threat modeling basics
• SBOM and patch strategy
• Cybersecurity monitoring actions

Module 6: Postmarket Surveillance and Lifecycle Reporting

• PMS plan and signals
• Complaint and vigilance flow
• Trending and metrics
• CAPA and effectiveness
• Periodic safety update
• Risk file maintenance

Exam Domains

1. Risk Governance and Lifecycle Integration
2. Hazard Identification and Analysis Methods
3. Risk Evaluation and Benefit-Risk Decisions
4. Risk Control Strategy and Verification
5. Usability and Software Assurance Integration
6. Postmarket Surveillance and Continuous Improvement

Course Delivery
The course is delivered through a combination of lectures, interactive discussions, and project-based learning, facilitated by experts in the field of Certified Medical Device Risk Manager. Participants will have access to online resources, including readings, case studies, and tools for practical exercises.

Assessment and Certification
Participants will be assessed through quizzes, assignments, and a capstone project. Upon successful completion of the course, participants will receive a certificate in Certified Medical Device Risk Manager.

Question Types

• Multiple Choice Questions (MCQs)
• Scenario-based Questions

Passing Criteria
To pass the Certified Medical Device Risk Manager Certification Training exam, candidates must achieve a score of 70% or higher.

Ready to lead ISO 14971-compliant risk programs that embed cybersecurity and patient safety into every release Join Tonex today and accelerate your path to CMDRM certification.