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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_2024
      • R-002-003 Quality indicators_2025
      • R-002-003 Quality indicators_2026
      • 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
    • GP-004 Vigilance system
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    • GP-007 Post-market surveillance
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    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • GP-023 Change control management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-011 Provision of service
    • GP-110 Esquema Nacional de Seguridad
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  • GP-002 Quality planning
  • R-002-004 Annual management review report 2026

R-002-004 Annual management review report 2026

DRAFT

This document is a draft. The management review meeting is planned for April 2026. Content will be finalized after the meeting.

Meeting details​

Planned Assistants​

NamePosition
Andy AguilarGeneral Manager
Taig Mac CarthyDesign & Development Manager
Alfonso MedelaTechnical Responsible & PRRC
Saray UgidosQuality Manager & PRRC

Place​

Online

Planned Date​

TBD (April 2026)

Inputs to be reviewed​

Company context, quality policy and objectives review​

SWOT and CAME analysis​

SWOT and CAME analysis will be performed and recorded at the R-002-006 SWOT and CAME analysis.

The company has reached a significant maturity level in 2025, having achieved MDR certification and obtained regulatory clearances in multiple markets (Brazil, USA). The team has grown and the regulatory knowledge is consolidated. The main challenges for 2026 are related to maintaining compliance across all markets, executing the FDA clinical study, and continuing to improve cybersecurity measures.

From these findings, the following main aspects will be discussed:

  • Maintain MDR certification and ensure compliance during BSI surveillance audits (Quality objective #1 of 2026)
  • Consolidate regulatory presence in approved markets and complete pending approvals (Quality objective #2 of 2026)
  • Continue cybersecurity improvement with annual penetration testing (Quality objective #3 of 2026)
  • Strengthen technical documentation management for multi-market compliance (Quality objective #4 of 2026)
  • Achieve higher customer satisfaction scores (Quality objective #5 of 2026)

Quality policy​

The Quality Policy Annex_1_Quality Policy was updated in Q1 2025 as planned in the previous management review. Any changes to the quality policy will be evaluated during this review.

Quality objectives​

Quality objectives for 2025 - To be reviewed​

2025 objectives are reflected in the R-002-001_Quality objectives list_2025 and will be reviewed during the meeting:

  1. Certify the medical device under MDR: To be evaluated
  2. Obtain regulatory clearance in new markets: To be evaluated
  3. Enhance cybersecurity: To be evaluated
  4. Strengthen technical documentation management among the different markets: To be evaluated
  5. Product meets customer expectations: To be evaluated
Quality objectives for 2026 - To be confirmed​

The proposed quality objectives for 2026 are reflected in the R-002-001_Quality objectives list_2026 and will be confirmed during the meeting:

  1. Maintain MDR certification and regulatory compliance: Focus on surveillance audits and continuous improvement.
  2. Consolidate regulatory presence in approved markets: Maintain approvals and complete Japan registration.
  3. Continuous cybersecurity improvement: Annual penetration testing and vulnerability monitoring.
  4. Strengthen technical documentation management: Extended from 2025 to implement automation improvements.
  5. Product meets customer expectations: Increased targets (CSAT > 80%, CUS > 75%).
Audit program 2025-2026​

The audit program for the period 2025-2026 will be reviewed and validated during this management review. The complete audit planning, including internal audits, BSI surveillance audits, and client audits, is documented in R-003-001_2025-2026_001 Audit program 2025-2026.

Feedback​

Feedback data from 2025 will be presented during the meeting:

  1. Direct consults through email, phone calls or contact form registered in Hubspot in accordance with GP-014 Feedback and complaints.

  2. Quarterly customer satisfaction surveys (CSAT) data.

  3. Clinical utility surveys results.

Treatment of complaints​

Complaints received in 2025 will be reviewed during the meeting in accordance with GP-014 Feedback and complaints.

Notifications to regulatory authorities​

Notifications made to Competent Health Authorities during 2025 will be summarized.

Audits​

External audits​

External audits performed during 2025 will be reviewed.

Internal audits​

Internal audit results will be reviewed.

Monitoring and measurement of processes​

Quality indicators review​

Quality indicators from R-002-003 Quality indicators will be reviewed.

Monitoring and measurement of the product​

Product performance in 2025 will be evaluated.

Nonconformities and Corrective and preventive actions (NC & CAPAs)​

NC & CAPAs status will be reviewed during the meeting.

Changes that could affect the QMS​

Changes implemented during 2025 will be reviewed. The following change control records are documented:

  • R-023-001_005: Changes to QMS processes (product development processes and adaptation to new requirements due to MDR transition)
  • R-023-001_006: New PRRC and QA/RA Manager
  • R-023-001_007: Change of AEMPS Technical Responsible and PRRC

Follow-up actions from previous management reviews​

Status of actions from 2024 management review will be verified.

Recommendations for improvement​

Recommendations will be discussed during the meeting.

New or revised applicable regulatory requirements​

New regulatory requirements will be reviewed:

Regulation/GuidanceUpdateDate
FDA Quality System Regulation (21 CFR 820) harmonized with ISO 13485New QSR effective February 2, 20262025-02
EU AI Act implementing measuresVarious implementing acts published2025
MDCG guidances updatesVarious updates to MDR implementation2025

Outputs - To be determined​

Necessary improvements to maintain the suitability, adequacy and effectiveness of the QMS and its processes​

To be determined during the meeting.

Product improvement in relation to customer requirements​

To be determined during the meeting.

Necessary changes to respond to new or revised applicable regulatory requirements​

To be determined during the meeting.

Necessary resources​

To be determined during the meeting.

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
Previous
R-002-004 Annual management review report 2025
Next
R-002-005 Quality Calendar_2025
  • Meeting details
    • Planned Assistants
    • Place
    • Planned Date
  • Inputs to be reviewed
    • Company context, quality policy and objectives review
      • SWOT and CAME analysis
      • Quality policy
      • Quality objectives
        • Quality objectives for 2025 - To be reviewed
        • Quality objectives for 2026 - To be confirmed
        • Audit program 2025-2026
    • Feedback
    • Treatment of complaints
    • Notifications to regulatory authorities
    • Audits
      • External audits
      • Internal audits
    • Monitoring and measurement of processes
      • Quality indicators review
    • Monitoring and measurement of the product
    • Nonconformities and Corrective and preventive actions (NC & CAPAs)
    • Changes that could affect the QMS
    • Follow-up actions from previous management reviews
    • Recommendations for improvement
    • New or revised applicable regulatory requirements
  • Outputs - To be determined
    • Necessary improvements to maintain the suitability, adequacy and effectiveness of the QMS and its processes
    • Product improvement in relation to customer requirements
    • Necessary changes to respond to new or revised applicable regulatory requirements
    • Necessary resources
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.)