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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
      • Annex 1 Responsibility matrix
      • Deprecated
      • Templates
        • T-001-001 Control of documents
        • T-001-002 Manufacturer declaration of conformity
        • T-001-005 List of external documents
        • T-001-006 IFU and label validation YYYY_nnn
        • T-001-007 Manufacturer declaration of conformity_MDR
        • T-001-008 _Device name_ label YYYY_nnn
        • T-001-009 Training on procedures of the QMS
      • Specific procedures
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-001 Control of documents
  • Templates
  • T-001-002 Manufacturer declaration of conformity

T-001-002 Manufacturer declaration of conformity

AI Labs Group, SL (hereinafter referred to as "us" or "we"), located at Gran Vía 1, BAT Tower, 48001 Bilbao, Bizkaia, Spain, hereby certify under our responsibility that the manufactured product and its version:

Legit.Health (version n.n)

Complies with the applicable regulations:

  • UNE-EN ISO 13485:2016 Quality management systems. Requirements for regulatory purposes.
  • UNE-EN 62304:2007/CORR:2009/A1:2016 Medical device software. Software life cycle processes.
  • UNE-EN ISO 14971:2019 Medical devices/health products. Application of risk management to MD.
  • UNE-EN ISO 15223-1: 2017 Health products. Symbols to be used on labels, labelling and information to be supplied.
  • UNE-EN 1041: 2009/A1:2014 Information provided by the manufacturer of medical devices.
  • UNE-EN 62366:2009/A1:2015 Application of usability engineering to medical devices.

And complies with the provisions of Council Directive 93/42/EEC for Medical Devices and issued exclusively under our responsibility.

Class I (Rule 12)

All documentation supporting this CE Declaration of Conformity is preserved in our document management system.

This document was issued in Bilbao, on the following date:

Approved by

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, JD-004
  • Approver: JD-001
JD-001 General Manager (GM)
No significant changes

There have been no significant changes in the design or intended use of the products, as defined in the MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.

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, JD-004
  • Approver: JD-001
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T-001-001 Control of documents
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T-001-005 List of external documents
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.)