Design Controls Cybersecurity Mapping

1. User Needs Identification

  • Cybersecurity Example: Identify the need for secure user authentication and encryption for patient data transmission.
  • FDA Guidance: Pre-market guidance stresses defining cybersecurity risks early to protect data confidentiality, integrity, and availability.
  • Traceability: Document user needs in a traceability matrix, linking them to specific security features like data encryption protocols.
  • SRS: Develop preliminary software requirements based on user needs, such as requiring compliance with TLS 1.2 or higher for data communication.

2-3. Design Input

  • Cybersecurity Example: Define detailed security inputs, such as secure boot mechanisms and strong password policies. Implement these requirements during development using secure coding practices, vulnerability assessments, and threat modeling.
  • FDA Guidance: The FDA emphasizes integrating security controls during the design process to address potential risks.
  • Traceability: Extend the traceability matrix to link design inputs to specific user needs and verification tests.
  • SRS: Create a comprehensive SRS that includes specifications for cryptographic algorithms, authentication mechanisms, and secure update processes.

4. Design Output

  • Cybersecurity Example: Produce finalized documentation detailing implemented security measures like intrusion detection systems and secure update capabilities.
  • FDA Guidance: Pre-market submissions require documentation of cybersecurity controls and their effectiveness.
  • Traceability: Link design outputs to design inputs in the traceability matrix to ensure all requirements are met.
  • SRS: Update the SRS to reflect final design specifications and include documentation on how software security requirements were addressed.

5. Design Verification

  • Cybersecurity Example: Perform penetration testing, static code analysis, and vulnerability scanning to verify the implementation of cybersecurity measures.
  • FDA Guidance: Verification tests should align with FDA pre-market guidance by demonstrating that cybersecurity requirements are met.
  • Traceability: Verify traceability from user needs to design inputs and outputs using test case results linked in the matrix.
  • SRS: Validate that software security requirements, such as encryption and authentication features, function as intended during verification testing.

6. Design Validation

  • Cybersecurity Example: Validate the device's security in real-world environments by simulating network attacks and verifying data protection measures.
  • FDA Guidance: Validation ensures that the device meets user needs and cybersecurity objectives as outlined in pre-market guidance.
  • Traceability: Cross-reference validation results with the traceability matrix to confirm the device fulfills all security-related user needs.
  • SRS: Confirm that software meets all functional and security requirements specified in the SRS.

7. Risk Management

  • Cybersecurity Example: Identify and mitigate risks such as vulnerabilities in wireless communication protocols or outdated software libraries.
  • FDA Guidance: Risk management is a continuous requirement in both pre-market and post-market FDA cybersecurity guidance.
  • Traceability: Use the traceability matrix to track risk mitigations across user needs, design inputs, and outputs.
  • SRS: Update the SRS to reflect changes made during risk management, including newly identified security requirements or mitigations.

8. Design Transfer

  • Cybersecurity Example: Ensure manufacturing processes adhere to cybersecurity specifications, such as secure firmware installation and tamper-evident seals.
  • FDA Guidance: The FDA pre-market guidance underscores the importance of maintaining security features during production and distribution.
  • Traceability: Verify that all design outputs and security controls are transferred accurately through the traceability matrix.
  • SRS: Provide manufacturing teams with an updated SRS that specifies software security requirements for production.

9. Post-Market Surveillance

  • Cybersecurity Example: Monitor for emerging vulnerabilities and release timely software patches to address them.
  • FDA Guidance: Post-market guidance emphasizes continuous monitoring, vulnerability patching, and incident response.
  • Traceability: Maintain traceability for software updates and security patches to ensure they align with initial user needs and mitigated risks.
  • SRS: Regularly review and update the SRS to incorporate new security features or address vulnerabilities identified post-market.

This integrated approach ensures security controls, traceability, and software requirements are aligned at each phase of design controls, complying with FDA guidance while building a robust cybersecurity foundation.