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  • Welcome to your QMS
  • Quality Manual
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    • GP-001 Documents and records control
    • GP-002 Quality planning
      • Deprecated
      • R-002-007
      • R-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • R-002-001 Quality objectives list_2026
      • R-002-002 Quality objectives_2024_001
      • R-002-002 Quality objectives_2024_002
      • R-002-002 Quality objectives_2024_003
      • R-002-002 Quality objectives_2024_004
      • R-002-002 Quality objectives_2024_005
      • R-002-002 Quality objectives_2025_001
      • R-002-002 Quality objectives_2025_002
      • R-002-002 Quality objectives_2025_003
      • R-002-002 Quality objectives_2025_004
      • R-002-002 Quality objectives_2025_005
      • R-002-002 Quality objectives_2026_001
      • R-002-002 Quality objectives_2026_002
      • R-002-002 Quality objectives_2026_003
      • R-002-002 Quality objectives_2026_004
      • R-002-002 Quality objectives_2026_005
      • R-002-003 Quality indicators
      • R-002-004 Annual management review report 2025
      • R-002-004 Annual management review report 2026
      • R-002-005 Quality Calendar_2025
      • R-002-005 Quality Calendar_2026
    • GP-003 Audits
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    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • GP-023 Change control management
    • GP-031 Training Data Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-110 Esquema Nacional de Seguridad
    • GP-200 Remote Data Acquisition in Clinical Investigations
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  • GP-002 Quality planning
  • R-002-001 Quality objectives list_2025

R-002-001 Quality objectives list_2025

List of objectives​

#Brief descriptionEstablishment dateStatusCompletion
1Certify the medical device under MDR2025-01-13Extended95%
2Obtain regulatory clearance in new markets2025-01-13Extended60%
3Enhance cybersecurity2025-01-13Completed100%
4Strengthen technical documentation management among the different markets2025-01-13Completed100%
5Product meets customer expectations2025-01-13Extended0%

Annual summary​

Overview​

StatusCountObjectivesOverall progress
Completed2#3, #4100%
Extended3#1, #2, #552% average
Total5All objectives71% weighted

Analysis by objective​

#ObjectiveAchievementClassificationQuality Impact
1MDR Certification95%External dependencyNone
2Regulatory clearance (new markets)60%Strategic prioritizationNone
3Cybersecurity enhancement100%CompletedN/A
4Technical documentation management100%CompletedN/A
5Customer satisfaction0%Strategic postponementNone

Conclusion​

2025 Quality objectives performance​

The 2025 quality objectives program demonstrates effective quality planning and execution, with two objectives fully completed and three objectives strategically extended to 2026.

Key achievements:

  • Objective #3 (Cybersecurity): Successfully completed the Dmed cybersecurity project including comprehensive penetration testing, strengthening the organization's cybersecurity posture.
  • Objective #4 (Technical documentation): All required MDR technical documentation has been submitted to BSI, establishing a robust documentation management system across markets.
  • Objective #1 (MDR): Achieved 95% completion with all CAPA actions implemented and accepted by BSI. Only the administrative certificate issuance remains.
  • Objective #2 (Regulatory): Brazil regulatory approval obtained (100% for this market), demonstrating international regulatory capability.

Strategic decisions documented: The three extended objectives are not the result of quality system failures but reflect:

  1. Objective #1: Dependency on BSI certificate issuance timeline (external factor beyond organizational control).
  2. Objective #2: Deliberate prioritization of MDR and FDA pathways to maximize resource efficiency and regulatory synergies.
  3. Objective #5: Conscious decision to collect customer feedback on the final MDR-certified product rather than the transitional MDD device.

Impact on Quality Management System​

No negative impact on QMS effectiveness has been identified. The analysis of each extended objective confirms:

  • Product quality and safety remain unaffected
  • Regulatory compliance is maintained (valid MDD certification, Brazil ANVISA approval)
  • Customer satisfaction channels remain active
  • All extensions are supported by documented strategic justifications

Confirmation for Management Review​

This quality objectives list and the associated individual objective records (R-002-002-2025-001 through R-002-002-2025-005) are ready for review during the April 2026 Management Review meeting. The extended objectives will be incorporated into the 2026 quality objectives planning as documented in R-002-001-2026.

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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R-002-001 Quality objectives list_2024_001
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R-002-001 Quality objectives list_2026
  • List of objectives
  • Annual summary
    • Overview
    • Analysis by objective
  • Conclusion
    • 2025 Quality objectives performance
    • Impact on Quality Management System
    • Confirmation for Management Review
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.)