• Welcome, Introduction, Training Goals
• Cybersecurity Threat Landscape: Why It Matters for Medical Devices
• Regulatory Frameworks & Standards, e.g.:
  • Medical Device Regulation (MDR)
  • Cyber Resilience Act (CRA)
  • Network and Information Security Directive 2 (NIS2)
  • FDA Guidance
  • ISO 14971
  • IEC 81001-5-1
  • IEC TR 60601-4-5
  • IEC 62443
• Secure Development Lifecycle - Risk Management & Security Governance
• Threat Modelling and Security Levels
• Security Requirements
• Secure Software Development Fundamentals
  • SW Exploitation
  • Technical Controls and Secure Architecture
  • Coding Guidelines
  • SW Toolchain
• Validating Device Security: Tools and Techniques for Testing
• Hardware & Embedded Security
• Post-Market Security - Vulnerability Handling & Incident Response
• Pitfalls & Lessons Learned from Real Incidents
• Q&A and Wrap-Up

As medical devices become more connected, cybersecurity is critical for ensuring patient safety and regulatory compliance.

This expert-led training provides an overview of medical device cybersecurity and equips R&D, QA, and regulatory teams with the tools to integrate cybersecurity into the full medical device development lifecycle.

Who should attend?

Engineers, who want to learn more about cybersecurity related to medical device development, such as:

• Medical Device Software Developers & Engineers
• Systems Architects
• Cybersecurity Specialists / Product Security Engineers
• Quality Assurance (QA) & Test Engineers
• Regulatory Affairs Professionals
• Risk Management & Safety Engineers

Basic experience in cybersecurity and functional safety is beneficial but not required.

For more details about the course topics, download the brochure on the top of the page