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.

Experts from the US, EU, and other global markets will share insights, approaches, and challenges. We’ll also explore the latest standards like IEC 81001-5-1 and AAMI TIR57, and how they influence risk management practices in the real world.

Agenda:

• Introduction (5–10 minutes):
  Kickoff with an overview of threat modeling in the SaMD space, including relevant guidance, standards, and regulatory expectations.
• Regional Perspectives:
• Speaker 1 (15 minutes): The US Approach – Focus on FDA expectations and AAMI TIR57
• Speaker 2 (15 minutes): The EU Lens – Integration with MDR, IEC 81001-5-1, and EN standards
• Speaker 3 (15 minutes): Rest of the World – Challenges and practices from other key markets (e.g., Japan, Australia, Canada)
• Panel Discussion (10 minutes):
  EU vs. US – Comparing strategies, understanding overlap and divergence, and the impact of emerging standards like IEC 81001-5-1 and AAMI TIR57.
• 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