Medical Device Software Cyber Risk Assessment Template

1. Device Identification

Device Name Model Manufacturer Software Version Description

2. Intended Use & Network Connectivity

Intended Use Network/Connectivity Interfaces

3. Asset Inventory

Asset	Type	Description

4. Threat Identification

Threat Source	Threat Event	Affected Asset

5. Vulnerability Identification

Vulnerability	Description	Affected Asset

6. Risk Analysis

Risk Description	Likelihood	Impact	Risk Level
	Low Medium High	Low Medium High
	Low Medium High	Low Medium High

7. Mitigation Measures

Risk	Mitigation Strategy	Status
		Implemented Planned Not Implemented
		Implemented Planned Not Implemented

8. Residual Risk Evaluation

Residual Risks & Justification

9. Review & Approval

Prepared by Date Approved by Date