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  • Welcome to your QMS
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  • TF_Legit.Health_Plus
    • Legit.Health Plus TF index
    • Legit.Health Plus STED
    • Legit.Health Plus description and specifications
    • R-TF-001-007 Declaration of conformity
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      • Evaluation
        • R-TF-015-001 Clinical Evaluation Plan_2023_001
        • R-TF-015-002 Preclinical and clinical evaluation record_2023_001
        • R-TF-015-003 Clinical Evaluation Report_2023_001
        • R-TF-015-007 Delaration of interest Clinical evaluation team_2023_001
        • R-TF-015-007 Delaration of interest Clinical evaluation team_2023_002
        • R-TF-015-007 Delaration of interest Clinical evaluation team 2023_003
        • R-TF-015-007 Delaration of interest Clinical evaluation team 2023_004
        • R-TF-015-007 Delaration of interest Clinical evaluation team 2023_005
        • R-TF-015-007 Delaration of interest Clinical evaluation team 2023_006
      • Investigation
      • R-TF-015-008 Clinical development plan_2023_002
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  • R-TF-015-007 Delaration of interest Clinical evaluation team 2023_005

R-TF-015-007 Delaration of interest Clinical evaluation team 2023_005

Declaration of interest​

I, María Diez, hereby declare my interests, including financial and non-financial, in relation to the evaluation of Legit.Health Plus as part of the Clinical Evaluation Report (CER) for AI Labs Group S.L. This declaration is made in accordance with the regulatory requirements and internal policies of our organization.

  • Education: studied Biology at the Complutense University of Madrid. In addition, she holds a PhD on Biochemistry and Molecular Biology by the same University.
  • Experience with the product/process/technology: With more than 7 years on Quality and Regulatory experience, started developing her abilities implementing a Quality Management system based on ISO 15189, CLIA and Spanish sanitary regulations (specific for medical laboratories), clinical studies and in vitro Software as medical device. On her last work experience she developed and integrated QMS combining the ISO 9001, ISO 13485, ISO 15189 and ISO 27001 regulations with the requirements established at the 2017/746 European in vitro medical device regulations, again for a Software as medical device.

I acknowledge and confirm the following:

  1. I am an employee of AI Labs Group S.L.
  2. I do not have direct financial interests or relationships, such as ownership of shares, patents, proprietary rights, or royalty agreements, related to Legit.Health Plus or its manufacturer that could influence my evaluation.
  3. I have not received any gifts, incentives, or contributions that may influence my judgment during the evaluation of the device.
  4. I understand that it is my responsibility to promptly disclose any potential conflict of interest that may arise during the course of the evaluation.

I acknowledge that the purpose of this declaration is to ensure transparency and the highest ethical standards in the evaluation of the device. By signing below, I confirm that I have disclosed all relevant interests to the best of my knowledge.

Record signature meaning​

  • Author: JD-004 María Diez
  • Clinical evaluator approval: JD-004 María Diez
  • General Manager approval: JD-001 Andy Aguilar
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R-TF-015-007 Delaration of interest Clinical evaluation team 2023_006
  • Declaration of interest
  • Record signature meaning
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.)