Date: November 3, 2026
Time: 2:00 PM EST
Format: Live Webinar
Medical device cybersecurity requirements continue to evolve as regulators place greater emphasis on protecting patients, healthcare systems, and sensitive data from emerging cyber threats. Manufacturers seeking FDA clearance or compliance with EU MDR must understand how cybersecurity expectations impact product design, risk management, testing, documentation, and post-market activities.
Join us for an informative webinar exploring the latest cybersecurity requirements and best practices for medical devices. We'll review FDA cybersecurity guidance, key international standards, software bill of materials (SBOM) requirements, vulnerability management strategies, and the testing activities manufacturers should implement to support regulatory submissions and ongoing compliance.
What You'll Learn
- FDA cybersecurity expectations for medical device submissions and quality system processes.
- The role of standards including IEC 81001-1, IEC 81001-5-1, UL 2900-2-1, ISO 27001, and HIPAA in a cybersecurity program.
- How to develop and manage cybersecurity documentation, including risk assessments, threat models, and cybersecurity management plans.
- Best practices for SBOM management, vulnerability monitoring, patching, and end-of-support planning.
- Cybersecurity testing approaches, including vulnerability assessments and penetration testing.
- Strategies for maintaining compliance through post-market monitoring and incident response activities.
Register Today
Whether you are preparing a new device submission, updating cybersecurity processes, or navigating evolving FDA and EU MDR expectations, this webinar will provide practical guidance to help strengthen your cybersecurity strategy and compliance readiness.
