Medical Device Cybersecurity Risk Management Standards & Regulations Training Course

Learning Objectives

• Describe the terminology and definitions related to medical device cybersecurity
• Identify the requirements for cybersecurity by design, including relevant standards, adversarial resilience analysis, remote access control, supply chain rigor, and requirements for premarket submissions in US and EU.
• Describe a proactive, risk-based approach in third-party collaboration, integrating cybersecurity-specific postmarket requirements, and working with researchers and organizations to identify emerging vulnerabilities and threats.
• Describe best practices for evidence capture during safety investigations that are independently reviewable, preserve information about the event (including chain of custody and tamper resistance) while avoiding privacy and surveillance concerns, and provide a mechanism for reapplication of knowledge.
• Identify mechanisms for resilience and containment, including minimizing exposures, creating secure environments for isolation and segmentation, creating visible and safe modes of failure, while preserving data integrity.
• Describe strategies for rapid, efficient cyber safety updates, such as automation and process documentation, secure update processes, stakeholder communication (including FDA), and OTS update verifications.

Major Topics

• Regulations, standards and guidance documents related to medical device cybersecurity
• Cybersecurity by Design, Third-Party Collaboration, Evidence Capture, Resilience and Containment, and Updates
• Risk-based approaches to threat modeling, attacker evaluation, and documentation

Who Should Attend

Recommended for risk managers, quality assurance professionals, auditors, engineers/testers, product managers and regulatory professionals working in medical device and in-vitro diagnostic organizations.