Meet-Up #22: Threat Modeling for SAMD Medical Devices – Global Perspectives

Overview:
In today’s increasingly connected medical landscape, ensuring the cybersecurity of Software as a Medical Device (SaMD) is more critical than ever. Threat modeling is a key activity to identify, evaluate, and mitigate potential security risks in the development and maintenance of SaMD.

Join us for an engaging session where we dive into the evolving regulatory and practical expectations for threat modeling across different regions.

We will share insights, approaches, and challenges with you when it comes to threat modelling. See full agenda below:

Agenda:

• Introduction (5–10 minutes):
  Kickoff with an overview of threat modeling in the SaMD space, including relevant guidance, standards, and regulatory expectations.
• Presentation (45-60 minutes):
• Cybersecurity requirements/deliverables (FDA & EU)
• Threat Modeling
• Security testing (static, dynamic, penetration testing etc)
• Vulnerability Monitoring & SBOMs
• Q&A (15 minutes):
  Open floor for attendees to ask questions, share experiences, and spark discussion with the panel.

Who Should Attend:

• Regulatory and compliance professionals working with SaMD
• Cybersecurity and risk management experts in medtech
• Product managers, engineers, and quality professionals involved in SaMD development
• Anyone interested in global medical device cybersecurity strategies

Key Takeaways:

• A practical understanding of threat modeling for SaMD
• Regional insights from leading voices in the US, EU, and global markets
• Awareness of evolving standards and how to navigate them
• Live discussion on current challenges and implementation strategies

Feedback Form:
Please fill out the feedback form, whether you joined or not we would like to hear from you. Your feedback will help us improve the format and the Meetup in general, so please dont be shy. The form can be found here.