Threat modeling is increasingly expected by regulators, yet many SaMD teams lack a structured, regulator-friendly approach. Unclear or overly technical threat models often fail to support FDA submissions.
This white paper explains how to perform threat modeling for SaMD products in a way that aligns with FDA expectations. It focuses on identifying realistic threats, mapping them to patient safety risks, and translating results into submission-ready documentation.
- Why FDA expects threat modeling for SaMD
- How to perform threat modeling without heavy tooling
- Mapping threats to cybersecurity and safety controls
- Using threat models to strengthen FDA documentation
- SaMD architects and engineers
- Product security teams
- Regulatory professionals supporting submissions