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Free Download – FDA Funded “Playbook for Threat Modeling Medical Devices”

MITRE and the Medical Device Innovation Consortium (MDIC), with funding by the U.S. Food and Drug Administration (FDA), has released “Playbook for Threat Modeling Medical Devices.” This educational resource provides a foundation that organizations can utilize to develop or refine their threat modeling practices. It reviews, in detail, the four questions that should be part of a structured threat modeling practice.

  • “What are we working on?”
  • “What can go wrong?”
  • “What are we going to do about it?” 
  • “Did we do a good job?”

The playbook concludes with considerations for implementing threat modeling including product safety risk management and challenges in organizational adoption as well as a section on methodologies and tools to help construct threat models.


 

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Playbook for Threat Modeling Medical Devices Download PDF