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        • R-001-002 2020_001 Manufacturer declaration of conformity
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  • R-001-002 2021_004 Manufacturer declaration of conformity

R-001-002 2021_004 Manufacturer declaration of conformity

Ai Labs Group SL, located at the Urquijo street, Bilbao, 48008 (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

D016C42874BF636CA56933FE94D3FFAB

Signer name: Andy Aguilar

Signing time: Sat, 08 May 2021 11:32:00 GMT

Reason: New version approval

JD-001 General Manager (GM)
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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.)