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    • GP-001 Documents and records control
      • Deprecated
        • R-001-001 Control of documents and records
        • R-001-001 Control of documents and records_2023_001
        • R-001-001 Control of documents and records 2023_002
        • R-001-001 Control of documents 2023_003
        • R-001-001 Control of documents 2023_003
        • R-001-002 2020_001 Manufacturer declaration of conformity
        • R-001-002 2021_001 Manufacturer declaration of conformity
        • R-001-002 2021_002 Manufacturer declaration of conformity
        • R-001-002 2021_003 Manufacturer declaration of conformity
        • R-001-002 2021_004 Manufacturer declaration of conformity
        • R-001-002 2023_001 Manufacturer declaration of conformity
        • R-001-002 Manufacturer declaration of conformity_2023_002
        • R-001-003 Backup copies control
        • R-001-004 Backup integrity verification
        • R-001-005 List of external documents_2023_001
        • R-001-005 List of external documents_2023_002
        • R-001-005 List of external documents_2023_003
        • R-001-005 List of external documents_2023_004
      • R-001-001 Control of documents
      • R-001-002 Manufacturer declaration of conformity for Brazil
      • R-001-002 Manufacturer declaration of conformity
      • R-001-005 List of external documents
      • R-001-008 Legit.Health Plus label for Brazil
      • R-001-009 Training on procedures of the QMS
      • R-001-009 Training on procedures of the QMS
      • R-001-009 Training on procedures of the QMS
      • R-001-009 Training on procedures of the QMS
      • R-001-009 Training on procedures of the QMS
    • GP-002 Quality planning
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    • GP-200 Remote Data Acquisition in Clinical Investigations
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  • GP-001 Documents and records control
  • Deprecated
  • R-001-002 2023_001 Manufacturer declaration of conformity

R-001-002 2023_001 Manufacturer declaration of conformity

Ai Labs Group SL, located at the Plaza de Ingeniero Torres Quevedo 1, 48013 (Spain), certifies under its responsibility that the manufactured product and its version:

Legit.Health 2.1

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 nº 93/42/EEC for Medical Devices and issued under the exclusive responsibility of Ai Labs Group SL.

Class I (Rule 12)

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

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

Approved by

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

84C01A585C7695C7CB48ACB9A8F97B71

Signer name: Andy Aguilar

Signing time: Tue, 14 Feb 2023 09:01:14 GMT

Reason: New version approval

JD-001 General Manager (GM)

Version control​

Reason for reviewDateVersion id
First version202010121
Software version included (1.0)202010232
Software version updated (1.1)202102183
Software version updated (1.2)202103204
Software version updated (2.0)202104205
Software version updated (2.1)202105086
Version control section included and manufacturer address updated202302147
Written byReviewed byApproved by

E-Signature (Appfire integration):

Signature logo

María Diez

C22C38E8083E2A387DF3AA3413FAAEC8

Signer name: María Diez

Signing time: Sat, 11 Feb 2023 07:41:19 GMT

Reason: Creation of document

E-Signature (Appfire integration):

Signature logo

Alfonso Medela

03853253D4CE3A79CA8A789FFFDD0CC5

Signer name: Alfonso Medela

Signing time: Mon, 13 Feb 2023 07:53:41 GMT

Reason: Reviewed

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

751989E70D20C952922A3665A446C209

Signer name: Andy Aguilar

Signing time: Tue, 14 Feb 2023 07:52:49 GMT

Reason: Approving document

Quality manager (QM)Technical manager (PRRC)General manager (GM)
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  • Version control
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.)