Certified Medical Device Cyber Risk Manager (CMCRM)

Certified Medical Device Cyber Risk Manager (CMCRM) Certification Program by Tonex

This program equips medical device leaders, engineers, and risk managers to understand and manage cyber risk across the entire device life cycle. Participants learn how clinical safety, quality systems, and digital threat exposure intersect in connected and software driven products. The course covers foundational risk concepts, global expectations, and the practical use of TIR57, TIR97, AAMI SW96, and SBOM practices in real programs.

Emphasis is placed on building traceable, defensible decisions that satisfy regulators and support patient safety. The cybersecurity dimension is woven through device architecture, data protection, and secure update strategies so that cyber threats are treated as integral patient safety hazards. By the end of the course, participants are prepared to lead cross functional risk reviews, communicate with clinical and regulatory stakeholders, and drive continuous improvement in medical device cybersecurity risk posture.

Learning Objectives

• Understand the end to end medical device risk management life cycle in regulated healthcare environments
• Interpret and apply key standards and guidance including TIR57, TIR97, AAMI SW96, and related frameworks
• Perform structured risk analyses that integrate clinical safety, usability, and technical failure modes
• Develop and maintain an effective SBOM strategy that supports vulnerability tracking and supplier oversight
• Integrate cybersecurity risk concepts into design controls, change control, and postmarket surveillance activities
• Communicate risk decisions clearly to regulators, auditors, clinicians, and executive stakeholders
• Strengthen organizational cybersecurity posture by embedding device risk management practices into existing quality systems

Audience

• Cybersecurity Professionals
• Medical device design and development engineers
• Product security and risk management leaders
• Quality assurance and regulatory affairs specialists
• Clinical IT and biomedical engineering staff
• Healthcare technology management and operations professionals
• Consultants and advisors supporting medical device manufacturers or healthcare providers

Program Modules

Module 1: Medical device cybersecurity risk foundations

• Core concepts of safety and cyber risk
• Device life cycle and system of systems thinking
• Overview of regulatory expectations for connected devices
• Mapping hazards, threats, and clinical impact
• Building a common risk language across functions
• Role of the cyber risk manager in governance

Module 2: Standards TIR57 TIR97 SW96 and SBOM practice

• Purpose and scope of AAMI TIR57 and TIR97
• Applying AAMI SW96 to software intensive devices
• SBOM structure, minimum data, and ownership
• Integrating SBOM with procurement and supplier management
• Using standards to justify risk decisions and controls
• Aligning internal procedures with evolving guidance

Module 3: Threat modeling and technical risk analysis

• Identifying assets, interfaces, and trust boundaries
• Common attack paths for medical devices and ecosystems
• Applying threat modeling methods to representative devices
• Linking threats to hazardous situations and harms
• Prioritizing controls using likelihood and impact reasoning
• Documenting analysis for audits and external review

Module 4: Secure design verification and postmarket vigilance

• Embedding security requirements into design inputs
• Verification and validation of security controls
• Secure update strategies and configuration management
• Vulnerability monitoring and coordinated disclosure processes
• Handling field issues, advisories, and corrections
• Feedback loops from postmarket data into design controls

Module 5: SBOM operationalization and supply chain assurance

• Building SBOM collection and maintenance workflows
• Assessing third party components and open source risk
• Mapping vulnerabilities to deployed product portfolios
• Working with suppliers on remediation and timelines
• Reporting and communication to regulators and customers
• Metrics for SBOM and supply chain cybersecurity maturity

Module 6: Governance communication and program maturity

• Defining roles, responsibilities, and decision rights
• Integrating risk management with quality and compliance systems
• Preparing evidence packages for audits and submissions
• Communicating risk posture to executives and boards
• Measuring program effectiveness and closing gaps
• Roadmap for continuous improvement in device cybersecurity

Exam Domains

1. Governance and leadership for medical device cyber risk programs
2. Regulatory alignment and standards based risk management
3. Technical risk analysis threat modeling and vulnerability handling
4. Secure design verification and postmarket cybersecurity surveillance
5. SBOM management supplier oversight and supply chain resilience
6. Cross functional communication metrics and program improvement

Course Delivery
The course is delivered through a combination of expert led lectures, interactive discussions, case based group work, and guided exercises focused on real medical device scenarios. Participants engage with practical examples that illustrate how to apply TIR57, TIR97, SW96, and SBOM concepts within existing quality and regulatory frameworks. Learning materials include curated readings, templates, and checklists designed to be reused in participants own organizations.

Assessment and Certification
Participants are assessed through quizzes, short written assignments, and an integrative final exercise that brings together governance, technical analysis, and postmarket considerations. Performance is evaluated on both conceptual understanding and the ability to apply risk management methods in realistic situations. Upon successful completion of the program and final assessment, participants receive the Certified Medical Device Cyber Risk Manager CMCRM Certification from Tonex.

Question Types

• Multiple Choice Questions MCQs
• Scenario based Questions

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

Position yourself as a trusted leader at the intersection of patient safety, regulation, and cybersecurity. Enroll in the Certified Medical Device Cyber Risk Manager CMCRM Certification Program by Tonex to gain practical, immediately applicable skills that strengthen your organization and protect patients in a rapidly evolving connected health ecosystem.