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      • 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
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  • GP-002 Quality planning
  • R-002-002 Quality objectives_2025_001

R-002-002 Quality objectives_2025_001

Objective details​

Objective number​

1

Description​

Certify the medical device under MDR

Establishment date​

January 2025

The objective was established 2 years ago and it has been extended during the annual management review on February 13, 2024 because it is not fully achieved in 2023. We decided to extend it again for 2025 because in 2024 we did not complete the MDR certification process.

Planning​

Responsible​

JD-005, JD-004

Departments involved​

As it is a huge objective, all the departments are involved, but the main departments developing the objective are Design & Development and Quality & Regulatory ones.

Planned actions for 2025 period​

  1. Finalise the first round of questions of the clinical review
  2. Address the nonconformities coming from the technical and clinical review in the established deadlines (main gaps identified by BSI after the third round of questions of the technical documentation: usability test, DHF requirements and tests documentation)

Resources needed​

  • Personnel for product development and quality and regulatory teams to address the nonconformities in the technical and clinical documentation.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 202570%Received nonconformities from BSI under the pilot trial scheme. Started addressing technical and clinical documentation gaps.Prepare CAPA Plan for all NCRs.
Q2 202580%Submitted CAPA Plan to BSI addressing all major nonconformities (M1-M5). Restructured DHF documentation according to IEC 62304.Implement corrective actions and await BSI feedback.
Q3 202590%BSI accepted CAPA Plan. Implemented all corrective actions in technical documentation. Created comprehensive AI/ML documentation suite.Finalize implementation and prepare for BSI final review.
Q4 202595%All corrective actions implemented and verified. BSI confirmed acceptance. Awaiting final CE mark certificate issuance expected Q2 2026.Continue monitoring BSI communications for certificate issuance.

Final status​

Status: Extended to 2026

The CAPA Plan was accepted by BSI and all corrective actions have been implemented. The CE mark certificate under MDR is expected to be issued in Q2 2026. This objective is extended to 2026 for final completion upon certificate issuance.

Related indicators​

The following quality indicators from R-002-003 are linked to this objective:

IDIndicatorTargetResult 2025Achieved
#4Number of design non-conformities≤51✅
#5Design inputs/outputs achievement≥95%100%✅
#6Number of requirements that fulfill expectations≥95%100%✅
#24Number of recalls00✅
#31Number of QMS non-conformities≤82✅

Analysis of non-achievement​

Impact assessment​

AreaImpactJustification
QMS effectivenessNo impactThe QMS has demonstrated its effectiveness throughout the MDR certification process. The CAPA Plan was successfully developed, implemented, and accepted by BSI, evidencing a mature quality system capable of addressing regulatory requirements.
Product quality and safetyNo impactAll technical corrective actions have been implemented and verified. The device continues to meet safety and performance requirements. The delay is administrative in nature (certificate issuance), not related to product quality.
Regulatory complianceNo impactThe organization maintains valid MDD certification while transitioning to MDR. BSI has accepted all corrective actions, confirming regulatory compliance. The transition is proceeding according to regulatory timelines.
Customer satisfactionNo impactCustomers continue receiving the certified MDD device. The MDR transition is transparent to end users and does not affect device availability or performance.

Root cause analysis​

The objective was not fully achieved in 2025 due to the following factors:

  1. Extended regulatory process: The MDR certification process under the BSI pilot trial scheme involved multiple rounds of documentation review and required comprehensive corrective actions for technical and clinical documentation.
  2. External dependency: The final certificate issuance timeline depends on BSI's internal processes and is outside the organization's control.
  3. Strategic prioritization: The organization prioritized thorough implementation of all corrective actions to ensure a robust submission, rather than rushing to meet an arbitrary deadline.

Classification: External factors and strategic decision. This is not a failure of the quality system but rather a consequence of the rigorous MDR certification process.

Corrective actions​

No corrective actions required.

All technical work has been completed successfully. The CAPA Plan was accepted by BSI, demonstrating that the organization's processes are effective. The remaining delay is purely administrative (certificate issuance by the Notified Body) and does not indicate any deficiency in the QMS.

Preventive measures in place:

  • Continuous monitoring of BSI communications
  • Proactive engagement with BSI to ensure timely certificate issuance
  • Maintenance of MDD certification until MDR certificate is received

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 2025 period
    • Resources needed
  • Monitoring and follow up
    • Final status
  • Related indicators
  • Analysis of non-achievement
    • Impact assessment
    • Root cause analysis
    • Corrective actions
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.)