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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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  • R-002-002 Quality objectives_2025_004

R-002-002 Quality objectives_2025_004

Objective details​

Objective number​

4

Description​

Strengthen technical documentation management among the different markets

Establishment date​

January 2025

This is a new quality objective identified for 2025 which aims to implement a robust system to manage the technical documentation (especially IFU) created for each new market.

This quality objective is triggered by the expansion in new markets to ensure regulatory compliance in each target market.

Planning​

Responsible​

JD-005, JD-003, JD-004

Departments involved​

The main departments involved in the implementation of this quality objective are the product development and quality & regulatory departments.

Planned actions for 2025 period​

  1. Define how to manage technical documentation per each country (especially IFU) based on applicable regulatory requirements
  2. Implement the defined strategy
  3. Maintain technical documentation up to date according to changes in products or any other information provided in the technical documentation

Resources needed​

Personnel from product development and quality & regulatory departments for documentation management and implementation.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 202525%Defined strategy for managing technical documentation per country, especially IFU. Established documentation structure for multi-market compliance.Implement documentation management strategy.
Q2 202550%Implemented documentation management system. Brazil-specific IFU completed and approved. Started USA-specific documentation.Continue with FDA documentation requirements.
Q3 202575%USA technical documentation aligned with FDA requirements. Documentation traceability improved across markets.Finalize MDR technical documentation for BSI submission.
Q4 2025100%Complete MDR technical documentation submitted to BSI. Documentation management system fully operational for all markets (EU, Brazil, USA).Maintain documentation up to date.

Final status​

Status: Completed ✅

Technical documentation management strategy successfully implemented:

  • MDR technical documentation completed and submitted to BSI
  • Multi-market documentation structure established (EU, Brazil, USA)
  • IFU management per country implemented
  • Documentation maintained up to date according to regulatory requirements

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%✅
#31Number of QMS non-conformities≤82✅

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
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