ANSI/AAMI SW96:2023 – Standard for Medical Device Security: Security Risk Management for Device Manufacturers Training by Tonex
This course provides comprehensive training on ANSI/AAMI SW96:2023, which establishes a standardized approach to managing security risks for medical devices. Participants will learn how to incorporate security risk management into the design, development, and lifecycle of medical devices, ensuring compliance with regulatory requirements and protection against emerging cyber threats.
Learning Objectives
By the end of the course, participants will be able to:
- Understand and apply the ANSI/AAMI SW96:2023 security risk management framework.
- Identify and analyze cybersecurity threats and vulnerabilities for medical devices.
- Develop risk management plans that align with SW96:2023 and regulatory requirements.
- Implement security controls to mitigate risks effectively.
- Transition seamlessly from premarket to postmarket security risk management.
- Develop and execute incident response plans for cybersecurity events.
- Document and communicate security risk management processes to stakeholders.
Audience
This course is tailored for:
- Medical Device Manufacturers: Engineers and managers responsible for device security.
- Cybersecurity Specialists: Professionals focused on securing medical devices against cyber threats.
- Regulatory Affairs Experts: Those ensuring compliance with global cybersecurity standards and regulations.
- Quality and Risk Management Professionals: Individuals involved in assessing and mitigating device security risks.
- Healthcare IT Leaders: Stakeholders ensuring secure integration of medical devices into healthcare systems.
- Product Managers: Leaders overseeing the lifecycle of medical device products.
Course Modules:
Day 1: Foundations of Medical Device Security Risk Management
Module 1: Introduction to ANSI/AAMI SW96:2023
- Overview and purpose of the standard
- The relationship between SW96:2023, ISO 14971, and FDA guidance
- Key concepts: Security risk, threats, vulnerabilities, and controls
Module 2: Medical Device Security Risk Management Framework
- The risk management process outlined in SW96:2023
- Integrating security risk management with traditional risk management practices
- Establishing a security risk management plan
Module 3: Identifying and Analyzing Security Risks
- Identifying potential cybersecurity threats and vulnerabilities in medical devices
- Techniques for assessing likelihood and impact of security risks
- Case Study: Analyzing risks for a connected medical device
Module 4: Regulatory Context and Compliance
- Regulatory expectations for security risk management (FDA, EU MDR, ISO standards)
- Role of SW96:2023 in regulatory submissions and audits
- Documentation best practices for compliance
Day 1 Workshop:
- Participants will draft a security risk management plan for a hypothetical medical device, identifying potential threats and defining initial controls.
Day 2: Advanced Security Risk Management Practices
Module 5: Risk Mitigation Strategies
- Designing and implementing effective security controls
- Balancing usability and security in medical devices
- Mitigation planning for high-risk scenarios
Module 6: Postmarket Risk Management Integration
- Transitioning from premarket to postmarket security risk management
- Monitoring and maintaining device security after deployment
- Handling vulnerabilities and updates in the field
Module 7: Cybersecurity Incident Response
- Developing an incident response plan as part of security risk management
- Best practices for managing and reporting security incidents
- Role of collaboration with external stakeholders (e.g., healthcare providers, regulators)
Module 8: Practical Application and Certification
- Simulation Exercise: Develop and present a comprehensive security risk management strategy for a medical device.
- Feedback and debrief on workshop outcomes.
- Certificate of Completion for ANSI/AAMI SW96:2023 course