Medical Device Security Risk Management Workshop

Medical Device Security Risk Management Workshop by Tonex

Medical Device Security Risk Management Workshop by Tonex equips professionals with the knowledge needed to identify, assess, and manage security risks across connected and software-driven medical devices. The course addresses practical risk management methods, device lifecycle considerations, regulatory expectations, and secure operational practices in healthcare technology environments. It helps teams balance patient safety, device performance, compliance, and resilience in increasingly connected clinical ecosystems. Stronger security controls reduce exposure to device tampering, ransomware, unsafe configurations, and data compromise. Effective medical device risk management also strengthens cybersecurity governance across manufacturers, hospitals, and integrators. As device connectivity expands, cybersecurity becomes essential to protecting care delivery, patient trust, and operational continuity.

Learning Objectives

• Understand the foundations of medical device security risk management in clinical and manufacturing environments
• Identify cyber-physical threats, vulnerabilities, and attack surfaces affecting modern medical devices
• Apply structured risk assessment methods to device design, deployment, maintenance, and retirement stages
• Interpret security expectations related to safety, privacy, compliance, and post-market responsibilities
• Evaluate third-party components, software dependencies, and connected ecosystems for security risk
• Strengthen cybersecurity decision-making for medical device programs, governance, and incident readiness

Audience

• Medical device engineers
• Product security managers
• Regulatory affairs professionals
• Healthcare technology managers
• Quality assurance specialists
• Risk management professionals
• Compliance officers
• System integrators
• Clinical engineering teams
• Cybersecurity Professionals

Course Modules

Module 1: Medical Device Security Foundations

• Medical device threat landscape
• Security and patient safety
• Connected care technology risks
• Cyber-physical system exposures
• Core risk management principles
• Security lifecycle overview

Module 2: Regulatory and Compliance Alignment

• FDA security expectations
• International standards overview
• Documentation and evidence needs
• Compliance mapping strategies
• Post-market security obligations
• Governance and accountability roles

Module 3: Risk Assessment and Analysis

• Asset identification methods
• Threat and vulnerability analysis
• Risk scoring approaches
• Safety-security relationship review
• Likelihood and impact evaluation
• Risk acceptance decisions

Module 4: Secure Design and Development

• Secure architecture principles
• Software component assurance
• Authentication and access control
• Data protection requirements
• Update and patch planning
• Secure configuration practices

Module 5: Operational Risk Management Practices

• Deployment environment assessment
• Network exposure management
• Third-party supplier risks
• Maintenance and service controls
• Logging and monitoring needs
• Change management discipline

Module 6: Incident Response and Resilience

• Device incident readiness
• Vulnerability disclosure coordination
• Containment and recovery actions
• Clinical continuity planning
• Root cause evaluation
• Continuous improvement measures

Build stronger security practices for connected healthcare technologies with Medical Device Security Risk Management Workshop by Tonex. This course is designed for organizations and professionals who need a clear, practical approach to managing risk while supporting safety, compliance, and operational resilience.