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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_005

R-002-002 Quality objectives_2025_005

Objective details​

Objective number​

5

Description​

Product meets customer expectations

Establishment date​

January 2025

This quality objective is an extension of the quality objective 5 established for 2024. Since the objective was not achieved in 2024, mainly due to vacancy in the customer success department (more details in the record R-002-002_2024_005), we decided to extend it in 2025 to ensure monitoring of customer satisfaction with our device.

Planning​

Responsible​

JD-016

Departments involved​

The main department involved in the achievement of this quality objective is the customer success department.

Planned actions for 2025 period​

Once we decide the method we will use to send the surveys to customers, we will share the surveys, gather the answers and analyse the results.

This quality objective aims to achieve the following:

  1. Customer satisfaction score (CSAT) > 75% measured quarterly and at the end of each clinical study
  2. Clinical utility score (CUS) > 70% measured every six months and at the end of each clinical study

Resources needed​

Personnel from the customer sucess team to implement the activities and follow up.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 20250%Objective on hold. Decision to postpone customer satisfaction surveys due to ongoing MDR transition process.Reassess timing after MDR certification progress.
Q2 20250%Continued on hold. Resources focused on MDR CAPA Plan implementation and FDA preparation.Monitor MDR certification timeline.
Q3 20250%Remained on hold. MDR certification process prioritized. Decision to wait for new MDR-certified device deployment before launching surveys.Plan survey deployment for post-MDR certification.
Q4 20250%Objective not initiated in 2025. Extended to 2026 pending MDR device deployment.Deploy CSAT/CUS surveys after MDR CE mark issuance.

Final status​

Status: Extended to 2026

This objective was not initiated in 2025 due to the ongoing MDR transition process. The decision was made to postpone customer satisfaction surveys until the new MDR-certified device is deployed. This ensures that customer feedback is collected on the final MDR-compliant product rather than the legacy MDD device.

The objective is extended to 2026 with the following targets:

  • CSAT > 75% measured quarterly
  • CUS > 70% measured every six months

Related indicators​

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

IDIndicatorTargetResult 2025Achieved
#19Complaints≤100✅
#33Number of customer complaints≤50✅

Analysis of non-achievement​

Impact assessment​

AreaImpactJustification
QMS effectivenessNo impactThe decision to postpone was made through the established quality planning process and documented appropriately. The QMS continues to function effectively, with other customer feedback channels (support tickets, direct communication) remaining active.
Product quality and safetyNo impactProduct quality and safety are independently assured through the design verification/validation process, post-market surveillance, and vigilance reporting. Customer satisfaction surveys are supplementary to these core quality assurance activities.
Regulatory complianceNo impactCustomer satisfaction surveys are not a regulatory requirement for medical device certification. Post-market surveillance and vigilance reporting requirements are fulfilled through separate, active processes documented in GP-008 and GP-010.
Customer satisfactionMinimal temporary impactCustomers continue to have access to support channels and can provide feedback through existing mechanisms. The delay ensures future surveys collect meaningful data on the final MDR-certified product rather than a transitional version.

Root cause analysis​

The objective showed 0% completion due to the following strategic factors:

  1. Strategic timing decision: Top management decided it would be counterproductive to survey customers about a device that is transitioning between regulatory frameworks (MDD to MDR). Collecting feedback on the "old" device would not provide actionable insights for the "new" MDR-certified product.
  2. Product transition period: During 2025, the device was in active transition with ongoing modifications to documentation and labeling for MDR compliance. Surveying customers during this transition period would capture an incomplete picture.
  3. Resource prioritization: The Customer Success team resources were aligned with the organization's primary objective (MDR certification) to support documentation and customer communication about the regulatory transition.
  4. Data quality consideration: Surveys conducted on the MDR-certified device will provide more valuable and actionable feedback for continuous improvement.

Classification: Strategic decision. The 0% completion is not a failure but a deliberate postponement to maximize the value of customer feedback data.

Corrective actions​

No corrective actions required.

The non-initiation of this objective was a conscious, documented strategic decision with the following justification:

  1. Not a process failure: The Customer Success team has the capability and tools to conduct surveys (as demonstrated in previous years).
  2. Value-driven approach: Collecting feedback on the MDR-certified device will provide higher-quality, more actionable data.
  3. Alternative feedback mechanisms: Customer feedback continues to be collected through:
    • Support ticket analysis
    • Direct customer communication
    • Clinical study feedback
    • Commercial team interactions

Actions for 2026:

  • Deploy CSAT and CUS surveys within Q2 2026, following MDR CE mark issuance
  • Establish baseline metrics for the MDR-certified device
  • Implement quarterly measurement cadence as originally planned
  • Report results in Q3 2026 Management Review

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.)