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QMS
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  • Quality Manual
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    • GP-001 Documents and records control
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Suppliers
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • 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
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-011 Provision of service
    • GP-110 Esquema Nacional de Seguridad
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  • GP-023 Change control management
  • R-023-001_005 Change control

R-023-001_005 Change control

Description​

  • Change name: Changes to QMS processes due to MDR transition
  • Change description: Adaptation of the Quality Management System (QMS) to comply with the new requirements established by the Medical Device Regulation (EU) 2017/745 (MDR). This includes modifications to product development processes, design and development documentation, software validation processes, and risk management documentation to ensure full compliance with MDR requirements during the transition from MDD to MDR.
  • Source of change: Regulatory change (MDR 2017/745 transition).

Impact analysis​

  • Regulatory impact: is the change classified as significant?
    • Yes (it requires notification to Regulatory Authorities): BSI (Notified Body) was notified as part of the MDR certification process.
    • No (it does not require notification to Regulatory Authorities)
  • Risk analysis impact: Risk management documentation was updated to comply with ISO 14971:2019 and MDR Annex I requirements. Risk-benefit analysis was enhanced according to MDR requirements.
  • Quality documentation impact:
    • GP-012 Design and development - Enhanced documentation requirements per MDR Annex II
    • GP-028 Post-market surveillance - New procedure created to comply with MDR Articles 83-86
    • GP-029 Clinical evaluation - New procedure created to comply with MDR Annex XIV
    • GP-030 Vigilance - Updated to align with MDR Article 87-92 vigilance requirements
    • Technical documentation structure updated per MDR Annex II and Annex III

Approval​

The change is approved.

Plan​

  • Update GP-012 Design and development to comply with MDR Annex II technical documentation requirements.
  • Create GP-028 Post-market surveillance procedure to comply with MDR Articles 83-86 and Annex III.
  • Create GP-029 Clinical evaluation procedure to comply with MDR Annex XIV requirements.
  • Update GP-030 Vigilance to align with MDR Article 87-92 and serious incident reporting requirements.
  • Restructure technical documentation according to MDR Annex II and Annex III.

Implementation​

Implementation date: 2025-06-30

Status

QMS changes implemented. Currently under review by BSI (Notified Body). Pending confirmation and CE marking under MDR.

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_006 Change control
  • Description
  • Impact analysis
  • Approval
  • Plan
  • Implementation
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.)