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      • 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
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      • R-002-005 Quality Calendar_2026
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  • R-002-002 Quality objectives_2026_001

R-002-002 Quality objectives_2026_001

DRAFT

This document is pending review.

Objective details​

Objective number​

1

Description​

Maintain MDR certification and regulatory compliance

Establishment date​

January 2026

This objective follows from the successful completion of the MDR certification in 2025. The focus now shifts to maintaining compliance, addressing any notified body findings, and ensuring continuous improvement of the technical documentation.

Planning​

Responsible​

JD-005, JD-004

Departments involved​

The main departments involved are Design & Development and Quality & Regulatory.

Planned actions for 2026 period​

  1. Address any findings from the first surveillance audit under MDR
  2. Maintain technical documentation up to date with any product changes
  3. Ensure timely submission of any significant changes to the notified body
  4. Prepare for and execute the annual surveillance audit
  5. Keep EUDAMED registration updated

Resources needed​

  • Personnel for product development and quality and regulatory teams to maintain compliance documentation.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 2026
Q2 2026
Q3 2026
Q4 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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  • Objective details
    • Objective number
    • Description
    • Establishment date
  • Planning
    • Responsible
    • Departments involved
    • Planned actions for 2026 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.)