Cybersecurity Risk Assessment & Threat Model

What it is: a professionally drafted template for the security risk assessment and threat modeling activities expected under Regulation (EU) 2017/745 Annex I GSPRs 17.2 and 17.4, MDCG 2019-16, and IEC 81001-5-1. It documents the systematic identification of threats, vulnerabilities, and security risks across the device’s interfaces and architecture, and their evaluation against defined acceptance criteria.

What is included

• Asset inventory: data, functions, interfaces, and communication channels
• Trust boundary definition with system context diagram guidance
• STRIDE-based threat identification per boundary and interface
• Threat/vulnerability scoring methodology (likelihood, exploitability, impact — CVSS-compatible)
• Security controls mapping with residual risk evaluation
• Interface with ISO 14971: security risks with safety impact fed into the risk management file
• Pre-built link to the SOUP/SBOM vulnerability monitoring process
• References to MDCG 2019-16, IEC 81001-5-1, and AAMI TIR57

Format: 1 fully editable file + slim README with usage instructions. Delivered as a small ZIP. Instant download after purchase.

Need the full lifecycle? This is 1 of 12 templates in the IEC 62304 & Cybersecurity Documentation Kit.