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    • GP-023 Change control management
      • R-023-001_001 Change control
      • R-023-001_002 Change control
      • R-023-001_003 Change control
      • R-023-001_004 Change control
      • R-023-001_005 Change control
      • R-023-001_006 Change control
      • R-023-001_007 Change control
      • R-023-001_008 Change control
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  • GP-023 Change control management
  • R-023-001_006 Change control

R-023-001_006 Change control

Description​

  • Change name: New PRRC and QA/RA Manager
  • Change description: Appointment of Saray Ugidos as the new Person Responsible for Regulatory Compliance (PRRC) and Quality Assurance/Regulatory Affairs Manager, replacing Giulia Foglia. This change involves updating the organizational structure, responsibilities, and associated QMS documentation to reflect the new appointment.
  • Source of change: Internal organizational change.

Impact analysis​

  • Regulatory impact: is the change classified as significant?
    • Yes (it requires notification to Regulatory Authorities): BSI was notified of the change in PRRC as required by MDR Article 15.
    • No (it does not require notification to Regulatory Authorities)
  • Risk analysis impact: No impact on risk analysis. The new PRRC meets all qualification requirements established in MDR Article 15.
  • Quality documentation impact:
    • Quality manual (organizational structure section)
    • Annex 2 - Organizational chart
    • R-008-001 Job descriptions - Update JD-004 assignment
    • R-008-003 Training records - New PRRC training evidence
    • PRRC qualification evidence and CV
    • BSI notification documentation

Approval​

The change is approved.

Plan​

  • Update the organizational chart in Annex 2 to reflect the new PRRC and QA/RA Manager.
  • Update the Quality manual organizational structure section.
  • Update R-008-001 Job descriptions to assign JD-004 to the new person.
  • Document PRRC qualification evidence per MDR Article 15 requirements.
  • Notify BSI of the change in PRRC.
  • Complete training records for the new QA/RA Manager.

Implementation​

Implementation date: 2025-03-01

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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R-023-001_005 Change control
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R-023-001_007 Change control
  • Description
  • Impact analysis
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