Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • 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
    • GSPR
    • Clinical
      • Evaluation
        • R-TF-015-001 Clinical Evaluation Plan
        • R-TF-015-002 Preclinical and clinical evaluation record_2023_001
        • R-TF-015-003 Clinical Evaluation Report
        • 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
    • Design and development
    • Design History File (DHF)
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
  • Licenses and accreditations
  • External documentation
  • TF_Legit.Health_Plus
  • Clinical
  • Evaluation
  • R-TF-015-007 Delaration of interest Clinical evaluation team_2023_001

R-TF-015-007 Delaration of interest Clinical evaluation team_2023_001

Version control​

Reason for reviewDateVersion id
First version202303071
Written byReviewed byApproved by

E-Signature (Appfire integration):

Signature logo

María Diez

2290A34E9B4917F53CCAC349D57CF78E

Signer name: María Diez

Signing time: Sat, 04 Mar 2023 12:04:34 GMT

Reason: Creation of document

E-Signature (Appfire integration):

Signature logo

Alfonso Medela

99D86F3A4BD87AFAF45D12EED5E3B5FE

Signer name: Alfonso Medela

Signing time: Mon, 06 Mar 2023 12:16:56 GMT

Reason: Reviewed

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

B1A5E521225F919FCD54B9965BF6E57B

Signer name: Andy Aguilar

Signing time: Tue, 07 Mar 2023 12:16:04 GMT

Reason: Approving document

Quality manager (QM)Technical manager (PRRC)General manager (GM)

Declaration of interest​

This declaration of interests is made and signed to document the possible conflicts of interest of M.D. María Belén Hirigoity, with NIE Y7674428D, as a participant of the clinical evaluation conducted by AI Labs Group S.L. for the Legit.Health Plus medical device, and with the following education and professional career:

  • Medical doctor degree from Universidad del Salvador, Buenos Aires, Argentina, with specializations in Dermatology from Bernardino Rivadavia Acute Care General Hospital.
  • Master's degree in Advanced aesthetic and Laser techniques from the University of Buenos Aires (UBA) and Universidad Cardenal Herrera (CEU UCH), Valencia, Spain.
  • Assistant professor on Dermatology at the University of Buenos Aires.
  • Assistant professor on aesthetic and laser techniques at the University of Buenos Aires postgrade and also at the University Cardenal Herrera Master.
  • Member of Tekderma medical team since 2021, working at 9 de Octubre Hospital and Alta Estética clinic, Valencia.
  • Medical advisor at Legit.Health.

M.D. María Belén Hirigoity, at present and in the previous months to this evaluation (from 2023), receives economics income in compensation for his work within the organization, not being his main professional activity.

Being certain all the information related regarding to the interests specified previously, M.D. María Belén Hirigoity certifies, under their responsibility, their technical independence in the realization of the clinical evaluation of the device.

Approver signature and dateClinical evaluator signature and date

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
General ManagerM.D. María Belén Hirigoity
Previous
R-TF-015-003 Clinical Evaluation Report
Next
R-TF-015-007 Delaration of interest Clinical evaluation team_2023_002
  • Version control
  • Declaration of interest
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.)