Medical devices are more connected, more software-driven, and more exposed than ever before. At the same time, regulators are raising expectations around secure-by-design practices, traceability, and lifecycle security. Yet many organizations still treat cybersecurity as a late-stage checklist item rather than a design input. The result is increasingly familiar: security gaps discovered too late, rushed mitigations, regulatory questions that stall submissions, and architectures that are fragile, hard to maintain, or unsafe under real-world attack scenarios. In a safety-critical industry, insecure design is no longer just a technical risk. It is a patient safety, business continuity, and regulatory risk.
This webinar focuses on how to design medical device systems securely from the ground up. Using real-world examples from connected and software-enabled medical devices, the session walks through how secure design and architecture should be approached during early development, not after implementation. Attendees will learn how to think about system boundaries, trust relationships, attack surfaces, and failure modes, and how those design decisions directly influence safety, resilience, and regulatory outcomes.
The presentation then connects design thinking to execution. Participants will learn how threat modeling, cybersecurity risk assessment, and security architecture views feed directly into clear, testable security requirements and controls. The webinar emphasizes practical techniques teams can apply immediately to improve traceability from risks to requirements to mitigations. It also shows how these artifacts align with modern regulatory expectations and standards, helping teams avoid rework, reduce surprises during review, and build systems that are defensible both technically and regulatorily.
If you are responsible for designing, developing, or approving connected medical devices, this webinar will give you a clearer, more confident path forward. Join us to learn how secure design and architecture can become a strength rather than a bottleneck in your development process. Register now to reserve your spot and build the foundation for safer, more resilient medical devices.
Key Learning Objectives
- Understand how insecure or incomplete design-time decisions create downstream cybersecurity, safety, and regulatory risks for medical device systems.
- Learn how to apply threat modeling and cybersecurity risk assessment early in development to inform secure system architecture decisions.
- Translate identified threats and risks into clear, traceable system and product security requirements and associated technical controls.
- Apply a practical secure-by-design approach that aligns with FDA expectations and modern standards to reduce rework, delays, and postmarket risk.
