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      • R-002-002 Quality objectives_2026_001
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  • R-002-002 Quality objectives_2026_003

R-002-002 Quality objectives_2026_003

DRAFT

This document is pending review.

Objective details​

Objective number​

3

Description​

Continuous cybersecurity improvement

Establishment date​

January 2026

This objective continues from 2025, building on the cybersecurity foundations established during the FDA submission process. The focus shifts to continuous monitoring, vulnerability management, and keeping up with evolving cybersecurity requirements.

Planning​

Responsible​

JD-005, JD-003, JD-004

Departments involved​

The main departments involved are Product Development, Operations, and Quality & Regulatory.

Planned actions for 2026 period​

  1. Conduct annual penetration testing
  2. Implement continuous vulnerability monitoring
  3. Address any new vulnerabilities in SOUP components
  4. Update cybersecurity documentation based on new threats or regulatory guidance
  5. Conduct cybersecurity training for relevant personnel
  6. Review and update threat models as needed
  7. Monitor FDA and EU cybersecurity guidance updates

Resources needed​

Personnel from the product development team for implementation; personnel from the operations team for monitoring; personnel from the regulatory & quality department for documentation and compliance oversight.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 2026
Q2 2026
Q3 2026
Q4 2026

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
  • Approver: JD-001 General Manager
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  • Objective details
    • Objective number
    • Description
    • Establishment date
  • Planning
    • Responsible
    • Departments involved
    • Planned actions for 2026 period
    • Resources needed
  • Monitoring and follow up
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)