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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_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
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  • 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 2025
Q2 2025
Q3 2025
Q4 2025

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
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.)