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    • GP-001 Documents and records control
      • Deprecated
      • 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
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Suppliers
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation
    • GP-023 Change control management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • TF_Legit.Health_Plus
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  • GP-001 Documents and records control
  • R-001-002 Manufacturer declaration of conformity

R-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 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 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 the document management system of the manufacturer.

This document was issued in Bilbao, on the following date: 2023-10-04

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)
No significant changes

There have been no significant changes in the design or intended use of the product as set out 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. We have issued a new document due to the update of the company's registered office.

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R-001-002 Manufacturer declaration of conformity for Brazil
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R-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.)