A well-prepared Test Summary Report (TSR) is essential for demonstrating the thoroughness and effectiveness of cybersecurity testing. Regulatory bodies, such as the FDA, TGA and MDR, emphasise clear, concise, and well-organized documentation to facilitate their reviews. This article outlines the key elements of a TSR, focusing on compliance and readability for regulatory reviewers.
Purpose of the Test Summary Report
- Testing Objectives - What the testing aimed to achieve.
- Scope - The boundaries and limitations of the testing.
- Key Findings - Highlighted vulnerabilities and their resolutions.
- Compliance Evidence - How the testing aligns with regulatory guidelines and standards.
Key Elements of a Test Summary Report
1. Report Overview
- Document Purpose: A brief introduction explaining why the TSR is being created.
- Device Information: Identify the device by name, model, and version.
- Testing Team and Contributors: List all contributors and their roles.
2. Testing Objectives
Outline the goals of the cybersecurity testing. For instance:
- Identify vulnerabilities.
- Validate security controls.
- Assess the device’s resistance to real-world attack scenarios.
3. Scope of Testing
Clearly define:
- Components Tested: Hardware, software, network interfaces, etc.
- Testing Types: Penetration testing, fuzz testing, vulnerability scanning, etc.
- Test Environment: Description of the setup, tools used, and simulations performed.
4. Testing Standards and Guidelines
Reference the standards and guidelines followed, such as:
- FDA Premarket Cybersecurity Guidance.
- IMDRF Principles for Medical Device Cybersecurity.
- ISO/IEC 27001 or 62304 (if applicable).
5. Test Results and Key Findings
- Overview of Findings: Summarize vulnerabilities, categorized by severity (Critical, High, Medium, Low).
- Risk Assessments: Include CVSS scores and their corresponding risk levels.
- Resolution Status: Indicate if vulnerabilities were mitigated, accepted, or require further investigation.
- Test Metrics: Highlight key statistics, such as:
- Number of vulnerabilities discovered.
- Average time to resolve critical issues.
6. Evidence of Testing
- Test Protocols: Summarize methods and processes used.
- Screenshots/Logs: Provide visual evidence or logs demonstrating the testing process.
- Tools Used: List software and hardware tools employed during testing.
7. Compliance and Risk Mitigation
- Regulatory Alignment: Confirm how testing complies with specific regulatory requirements.
- Mitigation Measures: Describe actions taken to address vulnerabilities.
- Residual Risks: Outline any remaining risks and the justification for their acceptance.
8. Conclusion
- Summarize the testing’s effectiveness in addressing cybersecurity risks.
- Include a statement of readiness for regulatory submission.
Tips for Making the Report Reviewer-Friendly
- Clarity and Conciseness: Use simple, direct language and avoid technical jargon unless necessary.
- Organized Layout: Use clear headings, bullet points, and tables for easy navigation.
- Visual Aids: Incorporate diagrams, charts, and tables to convey complex information efficiently.
- Traceability: Include a traceability matrix linking vulnerabilities to mitigation actions.
- Executive Summary: Provide a high-level summary upfront for quick reference.
A well-crafted Test Summary Report not only satisfies regulatory requirements but also instills confidence in the device’s cybersecurity measures. By adhering to the elements and best practices outlined above, your TSR can effectively communicate the robustness of your testing process to regulatory reviewers.
