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        • 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
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        • 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
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      • 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
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  • GP-001 Documents and records control
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  • R-001-002 Manufacturer declaration of conformity_2023_002

R-001-002 Manufacturer declaration of conformity_2023_002

Ai Labs Group SL, located at the Street Gran Vía 1, BAT Tower, 48001, Bilbao, Bizkaia (Spain), certifies under its responsibility that the manufactured product and its version:

Legit.Health v2.1

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

140AECCD74BAE6A4AE6548FE5B7D9C71

Signer name: Andy Aguilar

Signing time: Tue, 07 Mar 2023 13:29:24 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
Manufacturer address updated202303068
Written byReviewed byApproved by

E-Signature (Appfire integration):

Signature logo

María Diez

587984EFCB26BD941215578886A21BB5

Signer name: María Diez

Signing time: Fri, 03 Mar 2023 12:13:53 GMT

Reason: Creation of document

E-Signature (Appfire integration):

Signature logo

Alfonso Medela

8D049A98BE61183E67AF9A99A0CB1F0E

Signer name: Alfonso Medela

Signing time: Sun, 05 Mar 2023 12:26:15 GMT

Reason: Reviewed

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

3B1213A1B865AB0B54076E7F4134D45E

Signer name: Andy Aguilar

Signing time: Mon, 06 Mar 2023 12:25:23 GMT

Reason: Approving document

Quality manager (QM)Technical manager (PRRC)General manager (GM)
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R-001-003 Backup copies control
  • 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.)