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      • 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
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      • R-002-003 Quality indicators_2026
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      • R-002-004 Annual management review report 2026
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      • R-002-005 Quality Calendar_2026
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  • R-002-002 Quality objectives_2026_002

R-002-002 Quality objectives_2026_002

DRAFT

This document is pending review.

Objective details​

Objective number​

2

Description​

Consolidate regulatory presence in approved markets

Establishment date​

January 2026

This objective follows from the regulatory clearances obtained in 2025 (Brazil, USA, and other markets). The focus shifts to maintaining approvals, addressing post-market requirements, and potentially expanding to additional markets.

Planning​

Responsible​

JD-005, JD-004

Departments involved​

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

Planned actions for 2026 period​

Brazil (ANVISA)​

  1. Maintain ANVISA registration and comply with post-market requirements
  2. Submit any required annual reports or updates
  3. Address any ANVISA feedback or inspections

USA (FDA)​

  1. Maintain FDA 510(k) clearance
  2. Comply with post-market surveillance requirements
  3. Submit annual registration and listing updates
  4. Address any FDA feedback

Japan​

  1. Complete regulatory approval process if pending from 2025
  2. Establish post-market surveillance system
  3. Comply with PMDA requirements

Saudi Arabia​

  1. Maintain SFDA registration
  2. Comply with post-market requirements

Switzerland​

  1. Maintain registration through authorized representative
  2. Comply with Swissmedic requirements

Resources needed​

  • Personnel for product development and quality & regulatory departments to maintain compliance in all markets.

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
      • Brazil (ANVISA)
      • USA (FDA)
      • Japan
      • Saudi Arabia
      • Switzerland
    • 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.)