Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • 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
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
  • Pricing
  • Public tenders
  • Records
  • GP-023 Change control management
  • R-023-001_008 Change control

R-023-001_008 Change control

Description​

  • Change name: Reduction of ISO 13485 certificate scope - Removal of facial palsy assessment
  • Change description: Notification to BSI (Notified Body) to reduce the scope of the ISO 13485 certificate. The scope was changed from "Design, manufacture and distribution of software to support Health Care Practitioners in the assessment of skin structures and facial palsy" to "Design, manufacture and distribution of software to support Health Care Practitioners in the assessment of skin structures". The facial palsy assessment functionality was discontinued and removed from the certified product scope.
  • Source of change: Internal business decision to discontinue the facial palsy assessment functionality and focus exclusively on skin structure assessment.

Impact analysis​

  • Regulatory impact: is the change classified as significant?
    • Yes (it requires notification to Regulatory Authorities): BSI was notified to update the certificate scope.
    • No (it does not require notification to Regulatory Authorities)
  • Risk analysis impact: Risk analysis documentation updated to remove facial palsy-related hazards and risk controls. Residual risk profile simplified due to reduced scope.
  • Quality documentation impact:
    • ISO 13485 certificate (scope update)
    • Technical File (scope section)
    • Intended use/purpose documentation
    • Risk Management File (removal of facial palsy related hazards)
    • Clinical Evaluation Report (removal of facial palsy clinical data)
    • Instructions for Use (removal of facial palsy functionality)

Approval​

The change is approved.

RoleNameDate
OriginatorAlfonso Medela2025-11-15
JD-003Taig Mac Carthy2025-11-15
JD-001Andy Aguilar2025-11-15

Plan​

  1. Notify BSI of the scope reduction via Change Notification process.
  2. Update Technical File with revised scope and intended use.
  3. Update Risk Management File to remove facial palsy-related hazards.
  4. Update Clinical Evaluation Report to reflect revised scope.
  5. Update Instructions for Use to remove facial palsy functionality references.
  6. Archive previous documentation versions in Design History File.

Implementation​

Implementation date: 2025-12-01

BSI Notification:

  • BSI notification date: 2025-11-20
  • BSI acknowledgment received: 2025-12-10
  • Certificate scope updated by BSI: Pending confirmation at next surveillance audit
Status

Change implemented. BSI notified and scope change acknowledged. Certificate update to be confirmed during 2026 surveillance audit.

Retroactive documentation

This change control record was created retroactively on 2026-03-08 as part of corrective action for NCR 2780856-202603-N2 (BSI Surveillance Audit 2026). The change was properly notified to BSI but the internal change control record was not created at the time of the change.

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
ㅤ

Previous
R-023-001_007 Change control
Next
GP-031 Training Data Governance
  • 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.)