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  • Welcome to your QMS
  • 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-011 Provision of service
    • 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-031 Training Data Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-110 Esquema Nacional de Seguridad
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
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  • GP-023 Change control management
  • R-023-001_005 Change control

R-023-001_005 Change control

Description​

  • Change name: QMS restructuring for MDR transition and Technical File version 1.1.0.0
  • Change description: Major restructuring of the Quality Management System to comply with MDR 2017/745 requirements and to support the Technical File for Legit.Health Plus version 1.1.0.0. This restructuring includes creation of new procedures, reassignment of procedure codes, substantial rewriting of existing procedures, and simplification of others as part of continuous improvement.
  • Source of change: Regulatory change (MDR 2017/745 transition) and Technical File requirements for Legit.Health Plus v1.1.0.0.

Summary of changes​

The document responsibility matrix was reorganised from 9 groups to 14 groups, and all documents were re-signed accordingly.

Additionally, nine general procedures have undergone major (substantive) changes. The substantive changes fall into four categories:

  1. New procedures created to cover areas required by the expanded technical file (GP-028, GP-029, GP-030).
  2. Reassigned procedures: GP codes whose topic was replaced to better organise the QMS (GP-024, GP-025).
  3. Major restructuring of three existing procedures to reflect expanded scope and improve separation of concerns (GP-012, GP-013, GP-023).
  4. Simplification of existing procedures as continuous improvement (GP-002, GP-005).

Impact analysis​

  • Regulatory impact: is the change classified as significant?
    • Yes (it requires notification to Regulatory Authorities): BSI (Notified Body) notified as part of MDR certification process.
    • No (it does not require notification to Regulatory Authorities)
  • Risk analysis impact: Risk management documentation updated to comply with ISO 14971:2019, IEC 62304, and IEC 62366-1 under a unified framework. Risk-benefit analysis enhanced according to MDR requirements. Cybersecurity risk management absorbed into GP-013.
  • Quality documentation impact: See detailed changes below.

Detailed changes​

New procedures​

DocumentChangePeriodDescription
GP-028New procedureAug 2025 – Feb 2026AI/ML Development lifecycle
GP-029New procedureJul 2025 – Feb 2026Software Delivery and Commissioning
GP-030New procedureOct 2025 – Nov 2025Cyber Security Management (consolidated from GP-024 and SP-012-002)

Reassigned procedures​

DocumentChangePeriodDescription
GP-024ReassignedJul – Aug 2025Was "Cybersecurity" (moved to GP-030); now "Predetermined Change Control Plan"
GP-025ReassignedJun 2025Was "Corporate Governance" (moved to GP-027); now "Usability and Human Factors Engineering"

Substantially rewritten/expanded procedures​

DocumentChangePeriodDescription
GP-012RewrittenJul 2025 – Feb 2026Design, Redesign and Development: substantially rewritten; cybersecurity extracted
GP-013ExpandedAug – Oct 2025Risk Management: unified framework across 3 standards; absorbed cybersecurity scope
GP-023ExpandedAug 2025 – Feb 2026Change Control Management: expanded to cover reorganised QMS structure

Simplified procedures​

DocumentChangePeriodDescription
GP-002SimplifiedFeb 2026Quality Planning: process risk management simplified to annual review
GP-005SimplifiedFeb 2026Human Resources and Training: simplified; training updated for new procedures

Minor content changes​

DocumentDescription
GP-004, GP-007, GP-010, GP-018, GP-019, GP-027Content updates that do not alter the fundamental process

Approval​

The change is approved.

Plan​

  1. Create GP-028 AI Development procedure covering AI/ML model development lifecycle.
  2. Create GP-029 Software Delivery and Commissioning procedure covering software deployment and verification.
  3. Create GP-030 Cyber Security Management procedure consolidating cybersecurity content.
  4. Reassign GP-024 to Predetermined Change Control Plan (PCCP) for FDA and AI Act requirements.
  5. Reassign GP-025 to Usability and Human Factors Engineering for IEC 62366-1 compliance.
  6. Rewrite GP-012 Design, Redesign and Development with improved separation of concerns.
  7. Expand GP-013 Risk Management with unified framework (ISO 14971, IEC 62304, IEC 62366-1).
  8. Expand GP-023 Change Control Management for reorganised QMS structure.
  9. Simplify GP-002 Quality Planning and GP-005 Human Resources and Training.
  10. Update document responsibility matrix from 9 to 14 groups and re-sign all documents.

Implementation​

Implementation date: 2026-02-23

Status

QMS changes implemented. All procedures updated and signed. Technical File for Legit.Health Plus v1.1.0.0 submitted to BSI.

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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  • Description
  • Summary of changes
  • Impact analysis
  • Detailed changes
    • New procedures
    • Reassigned procedures
    • Substantially rewritten/expanded procedures
    • Simplified procedures
    • Minor content changes
  • 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.)